Systems and methods for orthopedic repair

ABSTRACT

According to some embodiments, an implant for correcting a deformity in or near a joint of a subject includes an implant body having an internal lumen, a suture side hole or window extending through a wall of the implant body and providing access to the internal lumen through an exterior of the implant body, a tension assembly comprising a first bone anchor and a second bone anchor, wherein the first and second bone anchors are configured to be placed on opposite sides of the implant body, and an adjustable suture loop coupling the first bone anchor to the second bone anchor, wherein at least a portion of the at least one adjustable suture loop is positioned within the internal lumen of the implant body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 16/246,307, filed Jan. 11, 2019, which is a continuation applicationof U.S. application Ser. No. 14/763,502, filed Jul. 24, 2015, now U.S.Pat. No. 10,179,012, which is the U.S. National Stage under 35 U.S.C. §371 of International Application PCT/US2014/013242, filed Jan. 27, 2014,titled Systems and Methods for Orthopedic Repair, which claims prioritybenefit of U.S. Provisional Application Nos. 61/757,553, filed Jan. 28,2013, and 61/914,341, filed Dec. 10, 2013. The entireties of all of theforegoing are hereby incorporated by reference herein.

FIELD

This application relates generally to implants for the repair oforthopedic deformities. More specifically, the application relates todevices and methods for stabilizing, supporting and compressing adjacentbones (e.g., phalanges) to eliminate motion and promote fusion.

BACKGROUND

Bone or joint fusion surgery (e.g., arthrodesis) can be performed torelieve arthritis pain in the ankles, wrists, fingers, thumbs, spineand/or other joints. In arthrodesis, two bones on each end of a jointare fused, eliminating movement along the joint. Joint fusion surgerycan be used in patients whose joints have eroded or have been destroyedor disfigured by osteoarthritis, rheumatoid arthritis, other forms ofarthritis and/or other diseases or conditions (e.g., hammer toe). Whilea fused joint loses flexibility, it can provide benefits with respect tobearing weight, stability, reduction of pain and the like.

SUMMARY

According to some embodiments, an implant for correcting a deformity(e.g., hammer toe, contracted toe, mallet toe, claw toe or relatedorthopedic deformities or conditions of the foot or hand, deformitiesresulting from osteoarthritis, rheumatoid arthritis, other inflammatorydiseases, accidents, generalized joint pain and/or other joint diseases)comprises an implant body comprising an internal lumen extending from afirst end to a second end of the implant body, wherein the implant bodyhaving a wall that defines one or more internal lumens. In someembodiments, the implant body comprises a suture side hole or windowextending through the wall of the implant body, wherein the suture sidehole or window is positioned between the first and second ends of theimplant body, and wherein the suture side hole or window provides accessto the at least one internal lumen through an exterior of the implantbody. In some embodiments, the implant further comprises a tensionassembly comprising a first bone anchor (and/or another type of boneengaging member) and a second bone anchor (and/or another type engagingmember), wherein the first and second bone anchors are configured to beplaced on opposite sides of the implant body when the implant isassembled for use. In some embodiments, the tension assembly furthercomprises at least one adjustable suture loop coupling, directly orindirectly, the first bone anchor to the second bone anchor, wherein atleast a portion of the at least one adjustable suture loop is positionedwithin the internal lumen of the implant body. In some embodiments, atleast a portion of the suture loop is routed or otherwise positionedoutside the body. In some embodiments, the suture loop comprises asuture line. In other embodiments, the suture loop comprises anelastomeric member or component. In some embodiments, the elastomericmember or component does not comprise a suture. In some embodiments, theat least one adjustable suture loop comprises at least one suture tailor free end that extends through the suture side hole and to an exteriorof the implant body, wherein, upon deployment and fixation of the firstand second bone anchors within bone bores of a subject and upon theapplication of tension to the at least one suture tail in a directionaway from the implant body, a tension between the first and second boneanchors is increased and/or maintained (e.g., to bring adjacent bonessecured to the implant closer and/or in contact with one another).

According to some embodiments, one or more both of the first and secondbone anchors comprise an outer anchor tube and an insert, the anchortube defining a longitudinal channel that receives the insert. In someembodiments, the outer anchor tube of the first and second bone anchorscomprises a plurality of fingers, barbs or other engagement members. Inone embodiment, such fingers, barbs or other engagement members arearranged radially at least partially around the outer anchor tube,wherein the fingers are configured to engage bone at an implantationsite (e.g., bone bore). In some embodiments, at least one of the firstand second bone anchors comprises an eyelet or securement element,wherein a portion of the at least one adjustable suture loop traversesthrough the eyelet or securement element to secure the at least oneadjustable suture loop to the corresponding bone anchor. According tosome embodiments, the implant body comprises a rigid, semi-rigid and/orflexible structure. In some embodiments, the implant body comprises oneor more rigid, semi-rigid and/or flexible materials. In one embodiment,the implant body comprises one or more of the following: a polymericmaterial (e.g., polyether ether ketone or PEEK), a metal or alloy (e.g.,stainless steel), an elastomeric material (e.g., rubber) and/or anyother natural or synthetic material.

According to some embodiments, the implant additionally comprises apositioning element located along the implant body, the positioningelement being configured to facilitate adjustment of the implant bodywithin corresponding bone bores of a subject once the implant has beenlocated therein. In some embodiments, the positioning system isincorporated with the tension system. In one embodiment, the positioningsystem includes at least a portion of the suture loop that comprises thetension system. In other embodiments, the positioning system is separateand distinct from the tension system.

According to some embodiments, the at least one adjustable suture loopcomprises at least one knotless construct or system, wherein the atleast one knotless construct or system includes a portion of the atleast one adjustable suture loop routed through an interior of a sectionof the at least one adjustable suture loop to create at least onelocking or friction section or portion. In some embodiments, the atleast one locking or friction section or portion of the knotless suturesystem permits a surgeon to create and maintain tension in the implant.In one embodiment, the tension created and maintained within the implantusing the knotless system does not require a surgeon to tie the suturesystem or otherwise secure the system separately from the knotlessconfiguration. According to some embodiments, at least one of the firstand second bone anchors comprises an eyelet or securement element,wherein a portion of the at least one adjustable suture loop traversesthrough the eyelet to secure the at least one adjustable suture loop tothe first and second bone anchors. According to some embodiments, theimplant body comprises a rigid, semi-rigid and/or flexible structure. Insome embodiments, the implant body comprises one or more rigid,semi-rigid and/or flexible materials. In one embodiment, the implantbody comprises one or more of the following: a polymeric material (e.g.,polyether ether ketone or PEEK), a metal or alloy (e.g., stainlesssteel), an elastomeric material (e.g., rubber) and/or any other naturalor synthetic material.

According to some embodiments, the at least one adjustable suture loopcomprises at least one knotless construct or system, the at least oneknotless construct or system comprising a portion of the at least oneadjustable suture loop routed through an interior of a section of the atleast one adjustable suture loop, wherein each of the first and secondbone anchors comprises an eyelet or securement element, wherein aportion of the at least one adjustable suture loop traverses through theeyelet to secure the at least one adjustable suture loop to the firstand second bone anchors. In some embodiments, the implant body comprisesa polymer or other rigid, semi-rigid and/or flexible material (e.g.,metal, elastomeric material, etc.). In some embodiments, thecross-sectional shape of the implant body is hexagonal or otherpolygonal shape (e.g., triangular, square or rectangular, pentagonal,octagonal, etc.).

According to some embodiments, the implant further comprises a slidingknot formed by the at least one adjustable suture loop, wherein thesliding knot is maintained within the interior lumen of the implantbody. In some embodiments, an outer dimension (e.g., diameter or othercross-sectional dimension) of the sliding knot is greater than thediameter or other cross-sectional dimension of the suture side hole orwindow.

According to some embodiments, the implant body comprises at least onepolymeric material, e.g., polyether ether ketone (PEEK), anotherpolymeric material, etc. In other embodiments, the implant bodycomprises a metal or alloy (e.g. stainless steel, brass, etc.), anelastomeric material (e.g., rubber) and/or any other natural orsynthetic materials, either in addition to or in lieu of at least onepolymeric material. In some embodiments, the implant body comprises botha polymeric material (e.g., PEEK) and a metal or alloy (e.g., Nitinol,stainless steel, etc.).

According to some embodiments, at least one of the first and second boneanchors comprises a plurality of deflectable fingers, barbs or otherexpandable elements or members configured to engage bone at animplantation site. In some embodiments, at least one of the first andsecond bone anchors comprises an eyelet or securement element (e.g.,positioned so that it faces the adjacent implant body), wherein aportion of the at least one adjustable suture loop traverses through theeyelet or securement element to secure the at least one adjustablesuture loop to the first and second bone anchors.

According to some embodiments, the at least one adjustable suture loopcomprises at least one knotless construct or design, wherein the atleast one knotless construct comprises a portion of the at least oneadjustable suture loop routed through an interior of a section of the atleast one adjustable suture loop.

According to some embodiments, the cross-sectional shape of the implantbody is polygonal (e.g., hexagonal, triangular, square or rectangular,pentagonal, octagonal, decagonal, etc.). In other embodiments, thecross-sectional shape of the implant body is at least partiallycircular, oval, curved, irregular and/or otherwise non-linear.

According to some embodiments, a length of the implant body is between15 and 20 mm (e.g., 15, 16, 17, 18, 19, 20 mm). In other embodiment, theimplant body is longer than 20 mm (e.g., 20-25 mm, 25-30 mm, 30-40 mm,40-50 mm, more than 50 mm, etc.) or shorter than 15 mm (e.g., 10-15 mm,5-10 mm, 0-5 mm, etc.). In some embodiments, an outer cross-sectiondimension (e.g., diameter) of the implant body is between 2 and 5 mm(e.g., 2, 3, 4, 5 mm). In other embodiments, the outer cross-sectiondimension (e.g., diameter) of the implant body is less than 2 mm (e.g.,0-0.5, 0.5-1, 1-1.5, 1.5-2 mm, etc.) or greater than 5 mm (e.g., 5-6,6-7, 7-8, 8-9, 9-10, 10-15, 15-20 mm, more than 20 mm, etc.).

According to some embodiments, the implant body comprises at least onebend or angle along its length. In some embodiments, a bend or anglealong the implant body helps provide a natural shape to the joint beingtreated (e.g. fused). In some embodiments, the angle or bend to theimplant body is about 0 to 30 degrees (e.g., 0-1, 1-2, 2-3, 3-4, 4-5,5-6, 6-7, 7-8, 8-9, 9-10, 10-11, 11-12, 12-13, 13-14, 14-15, 15-16,16-17, 17-18, 18-19, 19-20, 21-22, 22-23, 23-24, 24-25, 25-26, 26-27,27-28, 28-29, 29-30 degrees, etc.). In some embodiments, the bend orangle along the implant body is greater than 30 degrees (e.g., 30-35,35-40, 40-50 degrees, greater than 50 degrees, etc.).

According to some embodiments, the at least one adjustable suture loopcomprises polyethylene and/or another polymeric material. In someembodiments, at least a portion of the suture loop is routed orotherwise positioned outside the body. In some embodiments, the sutureloop comprises a suture line. In other embodiments, the suture loopcomprises an elastomeric member or component. In some embodiments, theelastomeric member or component does not comprise a suture. In someembodiments, the at least one suture loop comprises a flexible and/orresilient material.

According to some embodiments, a proximal and/or distal portion of theimplant body (e.g., along either side of a joint or other point offusion) is configured to extend across two or more bones (e.g.,phalanges). Thus, in some embodiments, an implant body is configured tospan across three or more bones.

According to some embodiments, method of correcting a deformity in ornear a joint of a subject (e.g., hammer toe, contracted toe, mallet toe,claw toe or related orthopedic deformities or conditions of the foot orhand, deformities resulting from osteoarthritis, rheumatoid arthritis,other inflammatory diseases, accidents, generalized joint pain and/orother joint diseases) comprises positioning a first bone anchor to animplant into a first bore located in a proximal bone (e.g., proximalphalange) of the subject, positioning a second bone anchor of theimplant into a second bore located in a distal bone (e.g., proximal orintermediate phalange) of the subject, deploying the first and secondbone anchors so that the first and second bone anchors engage adjacentbone tissue, positioning a proximal end of the implant body into thefirst bore of the proximal bone, positioning a distal end of the implantbody into the second bore of the distal bone and manipulating the atleast one suture tail of the at least one adjustable suture loop toincrease a tension between the first and second bone anchors. In someembodiments, increasing a tension between the first and second boneanchors creates compression between the proximal and distal bone topromote fusion.

According to some embodiments, manipulating the at least one suture tailof the at least one adjustable suture loop comprises moving the at leastone suture tail away from the implant body. In some embodiments, thesuture tail or free end is routed at least partially between the outsideof the implant body and the inside of the bone bore, such that thesuture tail or free end is positioned through a bore to the joint and/orthrough a longitudinal opening of the bone opposite of the joint.

According to some embodiments, the method further includes moving theimplant body further within the first bore or the second bore (e.g.,proximally and/or distally) prior to manipulating the at least onesuture tail. In some embodiments, moving the implant body further withinthe first bore or the second bore comprises manipulating a positioningelement of the implant body. In one embodiment, the positioning elementincludes the at least one suture tail of the at least one adjustablesuture loop. In other embodiments, the positioning element is separateand distinct from the tension system of the implant.

According to some embodiments, the method further comprises preparingadjacent surfaces of the joint prior to implanting the implant therein,wherein preparing adjacent surfaces of the joint comprises resectingbone tissue (e.g., using a rasp to at least partially remove bone and/orcartilage tissue along the bone(s) adjacent the targeted joint) and/ordrilling the first and second bores with in the bones. In someembodiments, the method further includes providing at least one graftmaterial and/or other bone-fusion promoting material or components at ornear the joint, before, during or after implantation of the implantwithin the targeted joint.

According to some embodiments, deploying the first and second boneanchors comprises radially expanding a plurality of deflectable fingers,barbs or members of each bone anchor. In one embodiment, the at leastone adjustable suture loop comprises at least one knotless construct ordesign, wherein the at least one knotless construct or design comprisesa portion of the at least one adjustable suture loop routed through aninterior of a section of the at least one adjustable suture loop.

According to some embodiments, a method of correcting a deformity in ornear a joint of a subject (e.g., hammer toe, contracted toe, mallet toe,claw toe or related orthopedic deformities or conditions of the foot orhand, deformities resulting from osteoarthritis, rheumatoid arthritis,other inflammatory diseases, accidents, generalized joint pain and/orother joint diseases) comprises positioning a first bone anchor of animplant into a first bore located in a proximal bone of the subject,wherein the implant comprises an implant body having an internal lumen,a suture window extending through a wall of the implant body, the suturewindow providing access to the internal lumen through an exterior of theimplant body. In some embodiments, the implant further comprises atension assembly having the first bone anchor and a second bone anchor,wherein the first and second bone anchors are located on opposite sidesof the implant body. In one embodiment, the tension assembly furthercomprises at least one adjustable suture loop coupling the first boneanchor to the second bone anchor, wherein at least a portion of the atleast one adjustable suture loop is positioned at least partially withinthe internal lumen of the implant body, the at least one adjustablesuture loop further comprising at least one suture tail that extendsthrough the suture window and to an exterior of the implant body. Insome embodiments, the method further includes positioning the secondbone anchor of the implant into a second bore located in a distal boneof the subject and deploying the first and second bone anchors so thatthe first and second bone anchors engage adjacent bone tissue of theproximal and distal bones. In some embodiments, the method additionallycomprises positioning a proximal end of the implant body into the firstbore of the proximal bone, positioning a distal end of the implant bodyinto the second bore of the distal bone and applying tension to the atleast one suture tail of the at least one adjustable suture loop tocreate compression between the proximal and distal bone to promotefusion.

According to some embodiments, applying tension to the at least onesuture tail of the at least one adjustable suture loop comprises movingthe at least one suture tail away from the implant body. In someembodiments, the method further includes moving the implant body furtherwithin the first bore or the second bore prior to manipulating the atleast one suture tail. In one embodiment, moving the implant bodyfurther within the first bore or the second bore comprises manipulatinga positioning element of the implant body. In some embodiments,positioning element includes the at least one suture tail of the atleast one adjustable suture loop. In some embodiments, the methodfurther comprises preparing adjacent surfaces of the joint prior toimplanting the implant therein, wherein preparing adjacent surfaces ofthe joint comprises resecting bone tissue along the joint and drillingthe first and second bores.

According to some embodiments, deploying the first and second boneanchors comprises radially expanding a plurality of deflectable fingersof each bone anchor. In some embodiments, the at least one adjustablesuture loop comprises at least one knotless construct or design, whereinthe at least one knotless construct or design comprises a portion of theat least one adjustable suture loop routed through an interior of asection of the at least one adjustable suture loop.

According to some embodiments, an implant for correcting a deformity inor near a joint of a subject comprises an implant body comprising alumen extending from a first end to a second end of the implant body,wherein the implant body comprises a window extending through a wall ofthe implant body, the window being positioned between the first andsecond ends of the implant body, and wherein the window provides accessto the internal lumen through an exterior of the implant body. In someembodiments, the implant further includes a tension assembly comprisinga first bone anchor, a second bone anchor and at least one adjustablesuture loop coupling the first bone anchor to the second bone anchor,wherein the implant body is positioned between the first and second boneanchors, and wherein at least a portion of the at least one adjustablesuture loop is positioned within the internal lumen of the implant body.In some embodiments, the at least one adjustable suture loop comprisesat least one suture tail that extends to an exterior of the implant bodythrough the window, wherein, upon deployment and fixation of the firstand second bone anchors within bone bores of a subject and upon theapplication of tension to the at least one suture tail in a directionaway from the implant body, a tension between the first and second boneanchors is increased, and wherein the at least one adjustable sutureloop comprises at least one knotless construct, the at least oneknotless construct comprising a portion of the at least one adjustablesuture loop routed through an interior of a section of the at least oneadjustable suture loop.

According to some embodiments, the at least one adjustable suture loopcomprises at least one knotless construct or system, the at least oneknotless construct or system comprising a portion of the at least oneadjustable suture loop routed through an interior of a section of the atleast one adjustable suture loop, wherein each of the first and secondbone anchors comprises an eyelet or securement element, wherein aportion of the at least one adjustable suture loop traverses through theeyelet to secure the at least one adjustable suture loop to the firstand second bone anchors. In some embodiments, the implant body comprisesa polymer or other rigid, semi-rigid and/or flexible material (e.g.,metal, elastomeric material, etc.). In some embodiments, thecross-sectional shape of the implant body is hexagonal or otherpolygonal shape (e.g., triangular, square or rectangular, pentagonal,octagonal, etc.).

According to some embodiments, the implant further comprises a slidingknot formed by the at least one adjustable suture loop, wherein thesliding knot is maintained within the interior lumen of the implantbody. In some embodiments, an outer dimension (e.g., diameter or othercross-sectional dimension) of the sliding knot is greater than thediameter or other cross-sectional dimension of the suture side hole orwindow.

According to some embodiments, the implant body comprises at least onepolymeric material, e.g., polyether ether ketone (PEEK), anotherpolymeric material, etc. In other embodiments, the implant bodycomprises a metal or alloy (e.g. stainless steel, brass, etc.), anelastomeric material (e.g., rubber) and/or any other natural orsynthetic materials, either in addition to or in lieu of at least onepolymeric material.

According to some embodiments, at least one of the first and second boneanchors comprises a plurality of deflectable fingers, barbs or otherexpandable elements or members configured to engage bone at animplantation site. In some embodiments, at least one of the first andsecond bone anchors comprises an eyelet or securement element (e.g.,positioned so that it faces the adjacent implant body), wherein aportion of the at least one adjustable suture loop traverses through theeyelet or securement element to secure the at least one adjustablesuture loop to the first and second bone anchors.

According to some embodiments, the at least one adjustable suture loopcomprises at least one knotless construct or design, wherein the atleast one knotless construct comprises a portion of the at least oneadjustable suture loop routed through an interior of a section of the atleast one adjustable suture loop.

According to some embodiments, the cross-sectional shape of the implantbody is polygonal (e.g., hexagonal, triangular, square or rectangular,pentagonal, octagonal, decagonal, etc.). In other embodiments, thecross-sectional shape of the implant body is at least partiallycircular, oval, curved, irregular and/or otherwise non-linear.

According to some embodiments, a length of the implant body is between15 and 20 mm (e.g., 15, 16, 17, 18, 19, 20 mm). In other embodiment, theimplant body is longer than 20 mm (e.g., 20-25 mm, 25-30 mm, 30-40 mm,40-50 mm, more than 50 mm, etc.) or shorter than 15 mm (e.g., 10-15 mm,5-10 mm, 0-5 mm, etc.). In some embodiments, an outer cross-sectiondimension (e.g., diameter) of the implant body is between 2 and 5 mm(e.g., 2, 3, 4, 5 mm). In other embodiments, the outer cross-sectiondimension (e.g., diameter) of the implant body is less than 2 mm (e.g.,0-0.5, 0.5-1, 1-1.5, 1.5-2 mm, etc.) or greater than 5 mm (e.g., 5-6,6-7, 7-8, 8-9, 9-10, 10-15, 15-20 mm, more than 20 mm, etc.).

According to some embodiments, the implant body comprises at least onebend or angle along its length. In some embodiments, a bend or anglealong the implant body helps provide a natural shape to the joint beingtreated (e.g. fused). In some embodiments, the angle or bend to theimplant body is about 0 to 30 degrees (e.g., 0-1, 1-2, 2-3, 3-4, 4-5,5-6, 6-7, 7-8, 8-9, 9-10, 10-11, 11-12, 12-13, 13-14, 14-15, 15-16,16-17, 17-18, 18-19, 19-20, 21-22, 22-23, 23-24, 24-25, 25-26, 26-27,27-28, 28-29, 29-30 degrees, etc.). In some embodiments, the bend orangle along the implant body is greater than 30 degrees (e.g., 30-35,35-40, 40-50 degrees, greater than 50 degrees, etc.).

According to some embodiments, the at least one adjustable suture loopcomprises polyethylene and/or another polymeric material. In someembodiments, at least a portion of the suture loop is routed orotherwise positioned outside the body. In some embodiments, the sutureloop comprises a suture line. In other embodiments, the suture loopcomprises an elastomeric member or component. In some embodiments, theelastomeric member or component does not comprise a suture. In someembodiments, the at least one suture loop comprises a flexible and/orresilient material.

According to some embodiments, the implant body and/or the bone anchors,are provided in a variety of sizes and shapes to accommodate fordifferent indications, applications, subject and/or the like. Suchimplant bodies and/or anchors can be provided to the surgeon or otheruser in a kit. For example, a kit can include implant bodies of varyinglengths and/or cross-sectional dimensions. In some embodiments, a kitincludes bone anchors of different diameters or sizes, implants ofvarying cross-sectional dimensions and/or lengths and suture loops ofvarying designs, sizes, lengths and/or other properties. Thus, a surgeonor other practitioner can advantageously customize a procedure bycombining various components. This can help provide for a moresuccessful treatment procedure by using components that are best sized,shaped and/or otherwise configured for a specific application or use. Inother embodiments, the implant body is configured be cut or otherwisereshaped in order to modify the implant for a particular use orapplication. Thus, is some embodiments, the implant body is provided inone or more lengths that can be shortened. In some embodiments, theimplant body comprises materials and/or a configuration that isconfigured to be cut or otherwise shortened. For example, in someembodiments, the implant body can include segments that are scored,perforated, undermined and/or otherwise configured to be cut alongcertain predetermined locations.

According to some embodiments, a method of correcting a deformity in ornear a joint of a subject comprises providing an implant, wherein theimplant comprises an implant body having an internal lumen, a windowextending through a wall of the implant body, the window providingaccess to the internal lumen, wherein the implant further comprises atension assembly having a first bone anchor and a second bone anchor,wherein the implant body is positioned generally between the first andsecond bone anchors. In some embodiments, the tension assembly furthercomprises at least one adjustable suture loop coupling the first boneanchor to the second bone anchor, wherein at least a portion of the atleast one adjustable suture loop is positioned at least partially withinthe internal lumen of the implant body, the at least one adjustablesuture loop further comprising at least one suture free end that extendsthrough the window and to an exterior of the implant body. In someembodiments, the second bone anchor of the implant is configured to bepositioned into a second bore located in a distal bone of the subject,wherein the first and second bone anchors are configured to be radiallyexpanded so that the first and second bone anchors engage adjacent bonetissue of the proximal and distal bones. In one embodiment, a proximalend of the implant body is configured to be positioned within the firstbore of the proximal bone, wherein a distal end of the implant body isconfigured to be positioned within the second bore of the distal bone.In some embodiments, upon an application of tension to the at least onesuture free end of the at least one adjustable suture loop is configuredto create compression between the proximal and distal bone to promotefusion by creating and sustaining tension between the first and secondbone anchors.

According to some embodiments, the implant body is configured to beselectively moved further within the first bore or the second bore(e.g., distally or proximally) by manipulating a positioning element ofthe implant body. In some embodiments, the positioning element includesthe at least one suture free end of the at least one adjustable sutureloop. In some embodiments, the first and second bone anchors areconfigured to be expanded by radial deployment of a plurality ofdeflectable fingers of each bone anchor. In one embodiment, the at leastone adjustable suture loop comprises at least one knotless construct,wherein the at least one knotless construct comprises a portion of theat least one adjustable suture loop routed through an interior of asection of the at least one adjustable suture loop.

The methods summarized above and set forth in further detail belowdescribe certain actions taken by a practitioner; however, it should beunderstood that they can also include the instruction of those actionsby another party. Thus, actions such as “positioning a proximal ordistal end of the implant body” include “instructing positioning aproximal or distal end of the implant body.”

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentapplication are described with reference to drawings of certainembodiments, which are intended to illustrate, but not to limit, thevarious inventions disclosed herein. It is to be understood that theattached drawings are for the purpose of illustrating concepts andembodiments of the present application and may not be to scale.

FIG. 1 illustrates a skeletal system of a human foot with an implantaccording to one embodiment implanted to treat a joint deformity;

FIG. 2A illustrates a cross-sectional view of an embodiment of anorthopedic repair implant;

FIG. 2B illustrates a cross-sectional view of the implant body of theimplant of FIG. 2A;

FIG. 3 illustrates a perspective side view of components of the tensionassembly of the implant depicted in FIG. 2A;

FIG. 4 illustrates a cross-sectional view of a bone anchor included theimplant of FIG. 2A;

FIG. 5 illustrates a cross-sectional view of an orthopedic repairimplant according to another embodiment;

FIG. 6 illustrates a perspective side view of components of the tensionassembly of the implant depicted in FIG. 5;

FIG. 7 illustrates a perspective view of the implant of FIG. 5;

FIG. 8 illustrates a cross-sectional view of an orthopedic repairimplant according to another embodiment;

FIG. 9 illustrates a perspective side view of the implant depicted inFIG. 8;

FIG. 10 illustrates a partial cross-sectional view of one embodiment ofan orthopedic repair implant;

FIG. 11 illustrates one embodiment of a bone anchor that can beincorporated into the implant depicted in FIG. 10;

FIGS. 12A and 12B illustrate different views of an orthopedic repairimplant according to another embodiment;

FIG. 12C illustrates an orthopedic repair implant according to anotherembodiment;

FIGS. 13-18 are schematic illustrations of sequential steps of a methodof treating a foot joint deformity using an orthopedic repair implantaccording to one embodiment; and

FIGS. 19 and 20 illustrate one embodiment of a knotless suture systemconfigured for use in the implant depicted in FIG. 12A.

DETAILED DESCRIPTION

The discussion and the figures illustrated and referenced hereindescribe various embodiments of an implant, as well as various tools,systems and methods related thereto. A number of these devices andassociated treatment methods are particularly well suited to treathammer toe, contracted toe, mallet toe, claw toe or related orthopedicdeformities or conditions of the foot. Such implants are configured tosecure to adjacent phalanges or other bones in a subject's foot or hand(or to another anatomical area of the subject, e.g., wrists, cervicaland/or other portions of the spine, other small joints, etc.) and topromote fusion or arthrodesis by reliably maintaining the adjacent bonesurfaces in compressive contact with each other over time. Suchembodiments can be used to treat deformities resulting from hammer toe,osteoarthritis, rheumatoid arthritis, other inflammatory diseases,accidents, generalized joint pain and/or other joint diseases. However,the various devices, systems, methods and other features of theembodiments disclosed herein may be utilized or applied to other typesof apparatuses, systems, procedures and/or methods, includingarrangements that have non-medical benefits or applications.

FIG. 1 illustrates a skeletal system 5 of a human foot F with an implant100 according to an embodiment disclosed in the present application inan implanted state to treat a joint deformity (e.g., hammer toe) oranother condition (e.g., other joint disease, fracture, etc.) of asubject. As shown and as discussed in greater detail herein, the implant10 can be configured span a joint J (e.g., a proximal interphalangealjoint, other joint of the foot or hand, wrist, spine, etc.) and caninclude a proximal portion 17 disposed and secured within a proximalbone PB (e.g., a proximal phalange), and a distal portion 22 disposedand secured within a distal bone DB (e.g., an intermediate phalange).According to some embodiments, an implant 100 can help re-align adjacentbones (e.g., across a joint) or bone portions (e.g., across a fracture),such as, for example, proximal and intermediate phalanges PB, DB. Thus,the implant 10 can assist in permanently fusing and/or otherwisestabilizing a joint J. In addition, as described in further detailherein, the implant 10 can be configured to urge the adjacent bones orbone portions (e.g., proximal and intermediate phalanges, PB, DB) towardone another and apply compression to the joint J (e.g., interphalangealjoint), thereby further enhancing joint stability and encouraging rapidarthrodesis or fusion of the bones at the joint 15.

According to some embodiments, an implantable orthopedic repair implantcomprises two or more elements, including, for example, an implant bodyand a tension assembly, which includes one or more bone anchors and/orother bone engaging members or features. The implant body can include arigid tubular support element that provides stability to help join twoadjacent bones. In some embodiments, the implant body comprises one ormore rigid polymers, other biocompatible, bioresorbable and/orosteoinductive materials and/or any other materials. In one embodiment,the implant body and/or any other portion of an implant can include oneor more radiolucent portions or components. In some embodiments, theimplant body comprises one or more metals (e.g., stainless steel),alloys, other natural and/or synthetic materials, elastomeric materialsand/or the like. In other embodiments, the implant body can comprisesone or more flexible and/or semi-rigid materials, either in lieu of orin addition to rigid materials, as desired or required.

According to some embodiments, the implant body comprises one or moreinternal lumens, at least partially through which one or more portionsof a tension assembly can be positioned. In some embodiments, theimplant body includes ribs or similar features that extend at leastpartially along the length of the body in a longitudinal direction. Suchribs or other features can help improve the rigidity of the implant,prevent rotational movement once embedded into bone and/or provide oneor more other advantages or benefits to the implant. In someembodiments, the cross-sectional shape of the implant body can vary, asdesired or required for a particular application or use. For example,the cross-sectional shape can be circular, oval, triangular, square orother rectangular, pentagonal, hexagonal, octagonal, other polygonal,irregular and/or the like. In one embodiment, the implant body comprisesa hexagonal cross-sectional shape that takes advantage of the exteriorcorners formed by adjacent sides of the body to help secure the implantbody within an implant site. Such configurations can help preventrotation or other movement in a target anatomical location (e.g., joint)after implantation.

As described in greater detail herein, the tension assembly can includean adjustable suture loop that is secured to bone anchoring elements(e.g., bone anchors, other bone-engaging members, etc.) positioned alongopposite sides (e.g., on either side of a sliding knot). The sutureloop, sliding knot and/or one or more other components of the tensionassembly can extend at least partially within the implant body (e.g.,within a lumen of the implant body). Such embodiments of an implantadvantageously permit surgeons to place anchors into adjacent bones (orbone portions), position the implant body into such bones (or boneportions) and subsequently manipulate a tension assembly to draw thebones or bone portions to each other. Thus, as described in greaterdetail herein, the suture loop of the tension assembly can help draw twobones anchors toward one another to create compression between the twoadjacent bones. The support, stability and compression help promotehealing and bone growth and thereby enhance a fusion or arthrodesisprocedure.

According to some embodiments, the tensioning of the suture loop of thetension assembly includes pulling on one or more suture tails or ends ofthe suture assembly. In turn, this can shorten the suture loop betweenthe opposing bone anchors to draw on or both of the anchors closer tothe implant body that is generally positioned between the anchors. Insome embodiments, the bone anchors can comprises one or more fingers,barbs and/or other engaging members to help secure the bone anchor toadjacent tissue of the subject's bone. As discussed with reference toseveral embodiments disclosed herein, the implant body can include asuture hole or window that runs through a side wall (e.g., in somearrangements, orthogonally, perpendicularly, diagonally or at somedesired angle relative to a lumen of the implant body). Such a side holeor window can form an internal wall which acts as an internal knotpusher for the sliding knot of the tension assembly. The side hole orwindow can advantageously permit one or more strands of the suturesystem to exit the interior lumen of the implant body so as to permit asurgeon or other practitioner to access and manipulate the suture systemduring an implantation procedure. Thus, in some embodiments, the outerdiameter (or other cross-sectional dimension) of the sliding knot islarger than the suture side hole or window to ensure the sliding knotremains advantageously fixed within the lumen of the implant body.

FIG. 2A illustrates a cross-sectional view of one embodiment of anorthopedic implant 100 that comprises an implant body 110 and a tensionassembly 120. As shown in FIGS. 2A and 2B, the implant body 110 caninclude a generally tubular shape which defines an inner lumen 130extending longitudinally through the implant body 110 (e.g., along acentral or major longitudinal axis). In some embodiments, thecross-sectional shape of the implant body can vary, as desired orrequired for a particular application or use. For example, thecross-sectional shape can be circular, oval, triangular, square or otherrectangular, pentagonal, hexagonal, octagonal, other polygonal,irregular and/or the like. In one embodiment, the implant body comprisesa hexagonal cross-sectional shape that takes advantage of the exteriorcorners formed by adjacent sides of the body to help secure the implantbody within an implant site. Such configurations can help preventrotation or other movement in a target anatomical location (e.g., joint)after implantation. The lumen 130 can extend form first and second openends 140, 150 of the implant body 110. In some embodiments, the implantbody 110 comprises one or more rigid polymeric materials, such as, forexample, polyether ether ketone (PEEK) polyphenylene, polysulfone,polyethylene, and the like. However, in other embodiments, the implantbody includes one or more other materials, including other rigidmaterials and/or semi-rigid and/or flexible materials, as desired orrequired by a particular application or use, such as for example, otherpolymeric materials, metals, alloys, other synthetic or naturalmaterials and/or the like.

With continued reference to FIGS. 2A and 2B, the implant body 110 caninclude a suture side hole or window 160 that extends from the innerlumen 130 to the exterior of the implant body 110. Such a side hole orwindow 160, which permits access to the inner lumen 130 from theexterior of the implant body, can be orthogonal or perpendicular to theaxis of the implant body and the lumen extending therethrough.Alternatively, the hole or window 160 can have any other angle (e.g.,between 0 and 90 degrees, such as, for example, 0-5, 5-10, 10-15, 15-20,20-25, 25-30, 30-35, 35-40, 40-45, 45-50, 50-55, 55-60, 60-65, 65-70,70-75, 75-80, 80-85, 85-90 degrees, angles between the foregoing, etc.)relative to the lumen, as desired or required. As shown in FIG. 2A, theimplant body 110 can include one or more ribs or other features ormembers 180 that extend at least partially (e.g., continuously orintermittently) along the length of the implant body 110 in alongitudinal direction. Such features or members 180 can help improvethe rigidity of the implant body, prevent rotational movement of theimplant body after implantation into a subject and/or provide one ormore other benefits or advantages. In other embodiments, however, theimplant body does not comprise such ribs or other external features.Instead, the implant body can comprise a polygonal cross-sectional shape(e.g., hexagonal, pentagonal, octagonal, square or other rectangular,triangular, etc.) along at least a portion of its length. Such aconfiguration can assist to prevent or reduce the likelihood that theimplant will rotate or otherwise undesirably move or shift during orafter implantation.

FIG. 3 illustrates one embodiment of a tension assembly 120 that can beincorporated into a bone fusion implant, such as the one depicted inFIGS. 2A and 2B, 10, 12 or any other implant disclosed herein. In someembodiments, the tension assembly 120 comprises a suture loop 200 thatincludes one or more strands or ends of a suture tail 210. The suturetail 210 can pass through the suture side hole or window 160 of theimplant body and form a sliding knot 220 which is held in at or near ajunction of the body's inner lumen 130 and the suture side hole orwindow 160. In other embodiments, as disclosed herein with reference tothe implant of FIG. 12, the suture system can include one or moreknotless systems (e.g., located within a lumen of the implant body) toassist in providing and maintaining the necessary tension to theimplant. Such a knotless design can be incorporated into any of theembodiments disclosed herein or variations thereof. In some embodiments,the outer dimension (e.g., outer diameter or other cross-sectiondimension) of the knot 220 is larger than the diameter or othercross-sectional dimension of the suture side hole or window 160 toensure that the knot 220 remains within the lumen. In some embodiments,the side hole or window 160 and the inner lumen 130 are configured toretain the knot 220 in a fixed position relative to the implant body110. In some embodiments, the suture side hole or window 160 is offsetfrom a central axis of the implant body 110 to facilitate implantation.

According to some embodiments, as illustrated, for example, in FIG. 2A,the suture loop 200 extends from the knot 220 through the inner lumen130 beyond the first end 140 of the implant body 110. The suture loop200 can be looped through a first eyelet or other securement feature(e.g., loop, recess, etc.) 230 of a first bone anchor 240 back throughthe first end 140. In addition, the suture loop 200 can extend beyondthe second end 150 to a second eyelet 250 of a second bone anchor 260.The suture loop 200 can terminate at a suture terminus 270 at or nearthe knot 220. In such an arrangement, as the suture tail 210 can beselectively pulled away from the implant body 110 to provide tension tothe tension assembly 120 in order to bring the first and second boneanchors 240, 260 towards one another (e.g., in a direction of theimplant body 110). In some embodiments, the suture system comprises twoor more suture tails 210, as desired or required, to provide more robustcontrol to the manipulation of the suture loop 200 and/or the boneanchors 240, 260 (and/or other bone engaging components) coupledthereto. In some embodiments, the knot 220 is configured so that whenopposing forces are applied on the knot (e.g., in the longitudinaldirection), the knot tightens to ensure that the first and secondanchors 240, 260 travel towards the implant body 110. As discussed ingreater detail herein, once radially deployed within corresponding bonebores, the bone anchors 240, 260 can be configured to affix to thecorresponding bone bores (e.g., at least in one direction) to ensurethat the tensile forces generated by the tension assembly 120 aremaintained and that adjacent bones (e.g., across a joint) are moved intocompressive contact with one another to promote fusion.

In some embodiments, the suture loop 200 is adjustable when the slidingknot 220 is held in a fixed position, for example within the inner lumen130 adjacent to the suture side hole or window 140. As the suture tail210 is tensioned or pulled away from the implant body 110, the tensileforce between the bone anchors 240, 260 is increased. This can cause thedistance between the bone anchors to be advantageously shortened. Thesize and shape of the orthopedic implant 100 can be modified, alternatedor otherwise configured or reconfigured according to a variety ofapplications or uses. For example, the implant 100 can be adapted forfusing bones in the hand or foot. Thus, the resulting implant may besmaller than an adaptation of the system for implantation in anotherportion of a subject's anatomy (e.g., wrist, cervical or other portionof a subject spine or neck). Accordingly, in some embodiments, thelength, thickness, size, shape, other dimensions and/or other propertiesof the implant body 110, bone anchors 240, 260, tension assembly (e.g.,suture loop) and the like can be adapted or customized according to acorresponding implant location and application.

FIG. 4 illustrates one embodiment of a bone anchor 240, 260 that may beincorporated into an implant, such as those depicted in FIGS. 2A and 2B,10 and 12A and/or any other configuration disclosed herein or variationthereof. As shown, the bone anchor 240, 260 can include an outer anchortube 300 and an insert 310. In one embodiment, the anchor tube 300defines a longitudinal channel 320 that is sized and/or otherwiseconfigured to receive the insert 310. The anchor tube 300 can include aplurality of barbs, fingers or other engaging members 330 arrangedradially at least partially about the anchor tube 300. Each barb orother engaging member 330 can extend from the anchor tube 300 outwardlyand can be configured to engage bone at the implantation site forsecuring the bone anchor. In some embodiments, the barbs or otherengaging members 330, once expanded, help form an interference orfriction fit between the anchor and the adjacent bone surface. In someembodiments, the insert comprises one or more polymeric materials (e.g.,PEEK), other rigid or semi-rigid materials (e.g. metals, alloys, etc.)and/or the like. Further, in some embodiments, the anchor tube 300 andone or more of its components (e.g., the barbs, fingers or otherengaging members 330) comprise a shape memory materials (e.g., Nitinol),other metals or alloys, polymeric materials, other resilient materialsand/or any other rigid, semi-rigid and/or flexible material, as desiredor required.

With continued reference to FIG. 4, the insert 310 can include a head340 and a shank 350 extending longitudinally from the head through theanchor tube 300. In some embodiments, an eyelet or other securementfeature, element, member or device 230, 250 is positioned at or near theend of the shank 350 (e.g., opposite the head 340). The eyelet orsecurement element 230, 250 can advantageously permits the suture loop200 to traverse through eyelet 230, 250 to secure the suture system tothe anchor and to provide the necessary tension to the implant (e.g., asthe suture tail 210 is tensioned by a surgeon or other practitioner).Other types of features or components configured to secure to the sutureloop 200 can be used, either in lieu of or in addition to eyelets.

For any of the implant embodiments disclosed herein, including withoutlimitation those depicted in FIGS. 2A and 2B, 10, 12A to 12C, etc.,other types of bone anchors can be incorporated into the implant design,such as, for example, screw-in bone anchors with various threadarrangements, other types of interference or friction fit bone anchorsand/or the like. Additional details regarding the bone anchorsillustrated herein are provided in U.S. Patent Publication No.2013/0211451, filed as U.S. patent application Ser. No. 13/673,626 onNov. 9, 2012 and published on Aug. 15, 2013, the entirety of which isincorporated by reference herein and explicitly made a part of thisspecification.

According to some embodiments, during an arthrodesis or fusionprocedure, portions of a pair of adjacent bones selected to be fused(e.g., the adjacent bones of a joint) are resected and a bore hole isdrilled into each the adjacent bones such that the bores aresubstantially parallel and opposing each other when an implant ispositioned therein. Thus, in some embodiments, it may be necessary toaccount for the amount of correction that is desired in a deformed jointin order to drill the bores in the adjacent bones. In some embodiments,in order to enhance the resulting fusion procedure, the adjacent bonesare resurfaced at least partially along the surfaces against which thebones will contact one another. For example, a rasp or other boneremoval device can be used to remove cartilage and/or bone tissue of oneor both bones that will be fused. Holes or openings can be created ineach of the bones so that the anchors, the implant body and othercomponents or portions of the implant can be secured therein.Accordingly, the size of the holes, bores or other openings created inthe bones can be carefully selected depending on the size of the implantto be used. In addition, the bores or other openings can be made largeenough to accept a cannula or other delivery tools or instrumentationthat will be used in the fusion procedure. According to any of theimplantations and fusion methods and procedures disclosed herein,preparation of the targeted bone surfaces (e.g., decertification,drilling, etc.) can be performed, at least in part, using the tools andother devices disclosed in U.S. Provisional Patent No. 61/887,132, filedOct. 4, 2013 and titled CIRCULATING BONE RASP, the entirety of which ishereby incorporated by reference herein and made a part of thisspecification.

In some embodiments, during insertion, the bone anchors 240, 260 arepositioned within a cannula of a delivery system such that the barbs orother bone engaging members of the anchor are deflected radiallyinwardly (e.g., toward the longitudinal axis of the bone anchor 240,260). The cannula can be withdrawn proximally to release the bone anchor240, 260 therefrom. Once released from the cannula, the barbs or otherengaging members of the bone anchor 240, 260 can self-expand radiallyoutwardly to bear against and engage the adjacent bone tissue of thebore or opening. This helps secure the bone anchor 240, 260 therein. Asdiscussed, for any of the embodiments disclosed herein or variationsthereof, the barbs or other engaging members or portions of a boneanchor incorporated into an implant can comprise Nitinol and/or othershape memory materials that are configured to self-expand. In otherconfigurations, one or more portions of a bone anchor can be activelyexpanded (e.g., using a radially expansion member). In some embodiments,the hole or bore is drilled deep enough into the target bone (e.g.,phalanges of a subject's foot or hand, cervical vertebra, etc.) toaccept the entire bone anchor 240, 260 and a portion of the implant body110. However, as discussed in greater detail herein, the depth, diameterand/or other properties of the bone bores can be carefully selected andcustomized depending on the implant and corresponding fusion procedureimplemented.

As discussed herein, the suture side hole or window 140 of the implantbody 110 can be offset from the central axis of the implant body. Insome embodiments, the bore hole that accepts the second bone anchor 260can be longer or deeper to accept a greater portion of the implant body110. Therefore, the bore hole which accepts the first bone anchor 140can be relatively short or shallow, as it is configured to receive ashorter portion of the implant body 110. However, as described herein,the implant body 110 can be configured to be advantageously movedrelative to the bore holes after initial placement in a subject. In thismanner, for example, a greater portion or length of the implant body canbe translated or moved into the distal bone to provide for more stableand reliable implantation across a joint. In some embodiments, thesuture side hole 140 is positioned in the implant body 110 such that itcoincides with an interface that is formed between the adjacent bonesonce they are pulled together. In other embodiments, the suture sidehole or window 140 can be positioned within the distal and/or proximalbone bore or opening, as desired or required. The offset arrangement ofthe suture side hole 140 can facilitate implantation and reduceprocedure time.

According to some embodiments, the first and second bone anchors 240,260 and the implant body 110 are arranged in a cannula of a deliverytool in a pre-arranged manner, such that each of the bone anchor 240,260 can be introduced into the corresponding bores or holes, eithersequentially or simultaneously. Once the bone anchors, the implant bodyand/or any other components of the implant have been properly positionedwith in the target bone bores, the cannula, delivery tools and/or otherinstrumentation can be withdrawn. As discussed in greater detail herein,the surgeon or other practitioner can manipulate the tension system(e.g., one or more tails or ends of a suture system) to properlyposition the implant within the subject and to create and maintain thenecessary tension and resulting compressive forces between the adjacentbones to promote fusion. The ability to create and maintain tension inthe suture system (and thus, to maintain compressive forces betweenadjacent bones) provides for enhanced and improved fusion of the bones.It also ensures that the surgeon or other practitioner can create andincrease the necessary compression within the targeted joint afterinitial implantation of the implant body.

With reference to FIG. 5, another embodiment of an implant 400 isillustrated. As with the system depicted in FIG. 2A, the implant 400 caninclude an implant body 410 and a tension assembly 420. In someembodiments, the implant body 410 comprises a rigid, semi-rigid and/orflexible structure that defines one or more inner lumens 430 that extendlongitudinally through the implant body 410. As with other implant bodyconfigurations disclosed herein, the implant body 410 can include apolygonal (e.g., hexagonal, octagonal, pentagonal, etc.) cross-sectionalshape. However, the implant body 410 can include any othercross-sectional shape, such as, for example, square, rectangular,triangular, circular, oval, irregular and/or the like, as desired orrequired. As shown, the implant 400 can include one or more anchors ateither end to help secure the system to a subject's bone tissue. Inaddition, in some embodiments, the implant body 410 comprises a sutureside hole or window 470 that extends from the inner lumen 430 to theexterior of the implant body 410, thereby allowing external access tothe inner lumen 430.

FIG. 6 illustrates one embodiment of a tension assembly 420 that can beincorporated into the implant of FIG. 5 or any other implant disclosedherein. In the depicted embodiment, the tension assembly 420 includesone bone anchor 500 that is separate from the implant body 410. As shownin FIGS. 5 and 7, a second bone anchor 460 is integrated into theimplant body 410, thereby forming a unitary structure with the implantbody. In some embodiments, the implant body 410 and the second boneanchor 460 can be releasably or permanently secured to one another, asdesired or required. Similar to other embodiments disclosed herein, atail or free end 510 of a suture loop 520 can be configured to passthrough a side hole or window 470 of the implant body 410. In someembodiments, the hole or window 470 is sized, shaped and otherwiseadapted to secure a knot 530 (e.g., a sliding knot) of the suture systemin place within the inner lumen 430 of the implant body 410.

With continued reference to FIGS. 5-7, a suture loop 520 can extend fromthe knot 530 through the inner lumen 430 of the implant body. Since theopposing bone anchor 460 is integrated into the implant body 410, thesuture loop 420 may not pass through a second eyelet. Rather, in someembodiments, the suture loop passes through only a single eyelet orsecurement element 540 (e.g., the eyelet or securement element of afirst bone anchor 500) and is fixedly terminated within the implant body410 at the suture terminus 550. The sliding knot 530 can be formed suchthat when opposing forces are applied on the sliding knot 530 (e.g., inthe longitudinal direction), the first bone anchor 500 is moved closerto the implant body and the integrated anchor and the knot tightens toensure that the anchor 500 and the implant body 410 remain fixedrelative to one another.

Unlike other configurations disclosed herein that include two boneanchors 240, 260 that are physically separated from the implant body110, the implant 400 embodiment illustrated in FIGS. 5-7 includes asingle independent bone anchor 500 and a bone anchor 460 which isintegrated into the implant body 410. In some embodiments, such anarrangement can reduce the complexity of the implant 400, improves arigidity and robustness of a planned orthopedic fusion and/or provideone or more additional benefits or advantages. In other embodiments,however, it may be preferred or desired to include separate anchors,based on the particular application or use of the implant.

FIGS. 8 and 9 illustrate another embodiment of an implant 600 that canbe used to treat hammer toe or another orthopedic deformity or conditionof a subject. As shown, the implant 600 can comprise an implant body 610and a tension assembly 620. The implant body 610 can include a rigid,semi-rigid and/or flexible structure that can have a generally tubularshape. In some embodiments, the cross-sectional shape of the implantbody 610 can be polygonal (e.g., hexagonal, octagonal, pentagonal,square or rectangular, triangular, etc.), circular or oval, irregularand/or any other shape, as desired or required. As disclosed herein withreference to other embodiments, the depicted implant body 610 caninclude one or more lumens 630 that extend longitudinally through it(e.g., along the central or major axis of the implant body 610, alonganother, non-central axis, etc.) to form at least one open end 640.Further, the implant body 610 can include a side hole or window 650 thatextends from the inner lumen 630 to the exterior of the implant body 610and that provides access to the inner lumen 630 from the exterior of theimplant body 610.

With continued reference to the cross-sectional view of FIG. 8, one endof the implant body 610 can include an expandable element 670 that isconfigured to be selectively radially expanded to help anchor theimplant body 610 within a bore or hole of a targeted bone. As shown, atone end of the lumen 630, the end opposite from the open end 640, theexpandable element 670 can include a longitudinal channel 675 that isconfigured to receive an expanding insert that expands the expandableelement 670. In some embodiments, such an insert can be larger indiameter or other cross-sectional dimension than the longitudinalchannel 675. Accordingly, when the expanding insert is pulled into thelongitudinal channel 675, the expanding element 670 is forced at leastpartially radially outwardly (e.g., as depicted schematically by thedashed lines in FIG. 8) to engage, at least partially, the inner wall ofthe bone bore or opening hole into which it is positioned. Thus, theexpandable element 670 can help create an interference or friction fitbetween the implant body 610 and the adjacent bone tissue. As notedherein with reference to the embodiment depicted in FIGS. 5-7, such aconfiguration can replace one of the separate bone anchors, and instead,integrate a similar one engaging member or feature into the implant bodyitself. Such a design can be incorporated into any of the implantembodiments disclosed herein, including, without limitation, theimplants of FIG. 10 or 12A-12C.

As illustrated in FIGS. 8 and 9, the tension assembly 620 can comprise asuture loop 680 having a suture tail or free end 690 that passes throughthe suture side hole or window 650. As with other embodiments disclosedherein, the depicted suture loop can be configured to form a knot 700(e.g., sliding knot) that is held in place within the inner lumen 430adjacent to the side hole or window 650. The suture loop 680 can extendfrom the knot 700 through the inner lumen 630 and beyond an open end 640of the implant body 610. The suture loop 680 can be looped through aneyelet or other securement element or feature 720 of a bone anchor 730and back through the open end 640. In some embodiments, the loop 680extends and is secured to an integrated bone anchor portion 670 a thatis integrated with the implant body 610 (e.g., along an opposite end ofthe body 610). The suture loop 680 can terminate at a suture terminus760 at or near the knot 700. As discussed above, a wedge or other insert750 located or positioned within the expandable element 670 of theintegrated bone anchor portion 670 a can be used as an expanding insertto at least partially force the expandable element 670 radiallyoutwardly so that at least a portion of the integrated bone anchorportion 670 a engages and secures to adjacent bone tissue of a subject.In some embodiments, the knot 700 is formed such that when opposingforces are applied on the knot 700 (e.g., in the longitudinaldirection), the knot tightens to ensure that the bone anchors or otherbone engaging components or features of the implant 730, 670 a remainfixed relative to one another.

With continued reference to FIGS. 8 and 9, in some embodiments, as thesuture tail 690 is tensioned or pulled away from the implant body 610,the suture loop 680 forces the separate bone anchor 730 towards the openend 640 of the implant body 630 and pulls the wedge or other expandinginsert 750 into the longitudinal channel 675 causing the expandableelement 670 to at least partially radially expand outwardly. In someembodiments, e.g., such as those illustrated in FIGS. 5-9, since a boneanchor or other bone engaging feature is integrated into the implantbody, the entire implant body forms an interference or friction fit withthe bore or hole of the targeted bone structure.

FIG. 10 illustrates a cross-sectional view of another embodiment of animplant 1000 used to treat hammer toe and/or another orthopedicdeformity or condition. As shown, the implant 1000 can include animplant body 1110 and a tension assembly 1120 at least partially routedtherethrough. As with other embodiments disclosed herein, the tensionassembly 1120 can comprise one or more bone anchors or other boneengaging components or elements. The bone anchors or other bone engagingelements or components can be separate from or integrated with theimplant body 1110, as desired or required. In some embodiments, theimplant 1000 can further include a positioning element 1125 that is usedto selectively move (e.g., translate along the longitudinal axis of theimplant body 1110) the implant body 1110. As discussed in greater detailherein, such movement of the implant body can occur after initialpositioning of the implant body within the corresponding bone bores oropenings.

According to some embodiments, the implant body 1110 can include arigid, semi-rigid and/or flexible structure having a polygonal (e.g.,hexagonal, square, other rectangular, triangular, pentagonal, octagonal,etc.) cross-sectional shape. In other embodiments, the implant body 1110can include a different cross-sectional shape, such as, for example,circular, oval, square, rectangular, triangular, other polygonal,irregular and/or the like. In some embodiments, the use of an implantbody 1110 having a polygonal shape helps ensure that the implant bodywill not rotate or otherwise move undesirably after completion of animplantation procedure. For example, the corners formed by the polygonalshape can provide for improved engagement with adjacent bone surfaces toreduce the likelihood of rotation or other movement when the implant issubject to various forces or moments post-implantation.

With continued reference to FIG. 10, the implant body 1110 can comprisean inner lumen 1130 that extends along a longitudinal axis of theimplant body 1110 from its open proximal end 1140 to its distal end1145. In other embodiments, the inner lumen 1110 extends only partiallywithin the implant body 1110. In addition, the implant body can includemore than one lumen (e.g., 2, 3, 4 lumens, more than 4 lumens, etc.), asdesired or required.

With continued reference to FIG. 10, the implant body 1110 can include asuture side hole or window 1150 that extends from the inner lumen 1130to the exterior of the implant body 1110. Although the implant body 1110illustrated herein is shown as generally straight, in other embodiments,the implant body 1110 may be formed with a bend having a desired angle.In some embodiments, the angle can vary between 0 and 30 degrees (e.g.,0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 19, 20,21, 22, 23, 24, 25, 26, 27, 28, 29, 30 degrees, values between theforegoing angle ranges, etc.), greater than 30 degrees (e.g., 30-40,40-50, 50-60 degrees, greater than 60 degrees, etc.), etc. In someembodiments, such a bend or angle in the implant body 1110 canapproximate the natural angle of the phalangeal bones adjacent thetargeted joint (e.g., the proximal and intermediate phalanges of asubject's foot, other phalangeal bones of a subject's foot or hand,etc.). Such a bend can help position the subject's toes, fingers orother bones in a more proper alignment and orientation followingimplantation of an implant. In some embodiments, the implant comprisestwo or more bends or angles. In other embodiments, the implant bodycomprises a non-linear shape along one or more portions. For example,one or more sections of the implant body can include a rounded or curvedshape, a sinusoidal shape, an irregular shape and/or the like.

In some embodiments, the implant body 1110 comprises one or more rigid,semi-rigid and/or flexible materials. For example, the implant body 1110can include one or more polymers, metals (e.g., stainless steel),alloys, other biocompatible, bioresorbable and/or osteoinductivematerials, radiolucent materials, elastomeric materials and/or any othermaterial. In some embodiments, the implant body 1110 comprises polyetherether ketone (PEEK), polyphenylene, polysulfone, polyethylene, or othersuitable polymeric materials.

According to some embodiments, the implant body 1110 can include one ormore longitudinal projections or ribs (e.g., extending along an exteriorof main implant body) that operate to enhance bone engagement, helpresist rotational movement of the implant body 1110 in situ and/orprovide additional advantages and benefits to the implant. Such ribs orprojections can extend continuously or intermittently along the lengthof the implant body. Further, the ribs or projections can extend alongcertain circumferential locations of the implant body (e.g., along every30, 45, 60, 90, 180 degrees, angles between the foregoing values, etc.).The ribs or projections 1110 can include any shape, size andconfiguration. For example, in some embodiments, the projections includea generally rectangular shape when viewed from the side, such that thedistance by which the projection extends from the exterior surface ofthe main portion of the implant body is constant or generally constantalong the length of the implant body. In other embodiments, however, theribs or other projections can include a different shape (e.g., circularor oval, curved, fluted, sinusoidal, triangular, other polygonal,stepped, irregular, etc.). Thus, is some configurations, the peripheralextent of a rib or projection relative to the exterior surface of themain portion of the implant body (e.g., when viewed from a cross-sectiongenerally perpendicular to the longitudinal axis of the implant body)varies along the length of the rib or projection. Such ribs orprojections can include one or more sharp surfaces or edges to provideenhanced engagement with adjacent bone tissue. In some embodiments, theradial extension distance of the ribs or projections is between 0 and 3mm (e.g., 0-0.5, 0.5-1, 1-1.5, 1.5-2, 2-2.5, 2.5-3 mm, lengths betweenthe foregoing values, more than 3 mm, etc.). In some embodiments, theradial extension distance of the ribs or projections is between 0 and100% of the diameter or cross-sectional dimension of the main portion ofthe implant body (e.g., 0-5, 5-10, 10-20, 20-30, 30-40, 40-50, 50-60,60-70, 70-80, 80-90, 90-100, 100-120, 120-140, 140-160, 160-180,180-200%, percentages between the foregoing values, greater than 200%,etc.). Such ribs or other projections can be incorporated into any ofthe implant body designs disclosed herein or variations thereof. Asnoted herein, alternatively or in addition to such ribs or projections,the implant body can include a polygonal cross-sectional shape (e.g.,hexagonal) that helps prevent the likelihood of rotation of the implantbody post implantation.

With continued reference to FIG. 10, a pair of through-holes or openings1165, 1166 can extend through the implant body 1110 to the inner lumen1130. A positioning element 1125, which in the illustrated embodimentcomprises a loop of suture material, can extend through thethrough-holes 1165, 1166 and can be accessible by a surgeon or otherpractitioner outside the implant body 1110. As discussed in greaterdetail herein, the positioning element 1125 can be used to adjust theposition of the implant body 1110 relative to the bone structures duringan implantation procedure, thereby facilitating the ease ofimplantation, enhancing the degree of stabilization provided by theimplant 1000 to the corresponding bone structures and/or providing oneor more other benefits and advantages. For example, the positioningelement 1125 and the corresponding features of the implant body 1110(e.g., the openings 1165, 1166 of the implant body 1110) can be used toadvance the implant body deeper into a distal bore or opening afterinitial positioning. In some embodiments, the surgeon can manipulate thepositioning element 1125 to apply a force in a desired direction. Thus,for example, the implant body (and, in some embodiments, an adjacentbone anchor) can be advantageously advanced, shifted or otherwise moveddeeper into a corresponding bone bore (e.g., distal or proximal).

In the embodiment illustrated in FIG. 10, the positioning element 1125comprises a suture loop extending through the through-holes 1165, 1166to couple the positioning element 1125 to the implant body 1110.However, in other embodiments, the positioning element 1125 includes adifferent configuration or method of attachment to the implant body1110, as desired or required. For example, in some embodiments, thepositioning element 1125 can include one or more tabs, openings, otherprojections or recesses, other features or components, combinations ofthe foregoing and/or the like positioned along a portion of the implantbody that can be used to move the implant body after the implant bodyhas been initially positioned within one or more bone bores of asubject.

In some embodiments, the positioning element 1125 can include anyflexible structure having the physical properties (e.g., tensilestrength, durability, etc.) sufficient to overcome tensile forcesapplied by the surgeon to it to transfer such forces to the implant bodyin order to adjust the position of the implant 1000 during theparticular procedure. In addition, in lieu of the through-holes oropenings 1165, 1166 included in the illustrated embodiment, in otherembodiments, the positioning element 125 can be attached to the implantbody 1110 by other devices, techniques or methods, such as, for example,adhesives, mechanical fasteners, friction or interference fitconnections, knots, pledgets and/or the like. Furthermore, while in theillustrated embodiment the implant 1000 includes a separate tensionassembly 1120 and positioning element 1125, in other embodiments, thefunctionality of these components can be provided in a single sutureassembly. For example, the tension system of FIGS. 12A-12C can be usedboth to create tension between the opposing bone anchors and to shift(or translate) the implant body relative to the distal and/or proximalbores after initial placement of the implant therein.

In the embodiment illustrated in FIG. 10, an expandable element 1170 ispositioned along a distal end 1145 of the implant body 1110. Theexpandable element 1170, when at least partially radially expanded, canbe used to engage the expandable element 1170 to adjacent bone tissue,and thereby, anchor the implant body 1110 within a targeted bore oropening. In some embodiments, the expandable element 1170 includes alongitudinal channel 1175 (e.g., along one or more interior portions)that is configured to at least partially accept a wedge or other insert1178 therein. In some embodiments, such an insert or wedge include anouter diameter or cross-sectional dimension that is larger than thediameter or other cross-sectional dimension of the longitudinal channel1175. Accordingly, in some embodiments, when the insert or wedge 1178 ispulled into the longitudinal channel, at least a portion of theexpandable element 1170 deflects radially outwardly to engage adjacentbone tissue of the corresponding bore in which it is positioned. Thus,in some configurations, an interference or friction fit is createdbetween the implant body 1110 and the bone itself upon radial expansionof the expandable element 1170 of the implant body 1110. Such aconfiguration can be incorporated into any of the implant embodimentsdisclosed herein or variations thereof.

As discussed in greater detail herein with reference to FIGS. 2A and 18,in other embodiments, an implant can include bone anchors (and/or otherbone engaging members or components) that are separate and distinct fromthe implant body 1110. A positioning assembly can be incorporated intoany of the implant embodiments disclosed herein or variations thereof.As discussed above, such a positioning assembly can includethrough-holes or openings through which a suture loop (or other flexiblemember) can be positioned. Alternatively, the positioning assembly caninclude a different configuration that enables a surgeon or otherpractitioner to selectively move the implant body of the implant afterinitial positioning within a target anatomical location (e.g., withinopposing bores on either side of a joint, fracture, etc.).

With continued reference to FIG. 10, as with other embodiments disclosedherein, the tension assembly 1120 can comprise a suture loop 1180 havingone or more suture tails or free ends 1190 that pass through a sutureside-hole or window 1150 of the implant body 1110 and help form asliding knot 120, knotless suture system and/or the like therein. Insome embodiments, the knot 120 is securely held in place within theinner lumen 1130 of the implant body 1110 adjacent to suture side holeor window 1150, such that the position of the knot 120 does not moveduring use. As discussed in greater detail herein, the knot can besized, shaped and otherwise configured to be retained within the lumenof the implant body 1110 during use. For example, the diameter orcross-sectional dimension of the knot can be larger than the diameter orcross-sectional dimension of the side-hole or window 1150 so that theknot cannot exit the lumen of the implant body. In some embodiments, thediameter or cross-sectional dimension of the knot is approximately 0 to30% (e.g., 1, 2, 3, 4, 5, 5-10, 10-15, 15-20, 20-25, 25-30%, percentagesbetween the foregoing values, less than 1%, etc.) larger or more than30% larger (e.g., 30-40, 40-50, more than 50%, etc.) than the diameteror cross-sectional dimension of the side-hole or window 1150.

As shown in FIG. 10, the suture loop 1180 can extend from the formedknot 120 through the inner lumen 1130. In some arrangements, the sutureloop 1180 is routed beyond the open end 1140 of the implant body 1110,positioned through an eyelet or other securement feature 1220 of a boneanchor 1230 and back through the open end 1140. The suture loop 1180 cancontinue through the inner lumen 1130 of the implant body 1110 andthrough an eyelet or other securement feature 1240 of the wedge orinsert 1178. In some embodiments, the wedge or insert 1178 is configuredto force the expandable element 1170 radially or laterally outwardlywhen moved into an interior portion of the expandable element 1170. Thiscan cause the expandable element 1170 to at least partially engageadjacent bone of the target bore or hole in which the implant body 1110is positioned. According to some arrangements, the knot 1200 is designedand configured such that when opposing forces are applied on the knot1200 in the longitudinal direction (e.g., by selectively manipulatingthe suture tails or free ends 1190 of the suture assembly 1120), theknot tightens to apply and maintain tension between the bone anchor 1230and the expandable element 1170 along the opposite end of the implant.As discussed herein with reference to FIGS. 2A and 12A-12C, theexpandable element 1170 or other bone engaging portion that isintegrated into the structure of the implant body 1110 can be separateand distinct from the implant body 1110. Accordingly, in someembodiments, two separate an opposing bone anchors can be used on eitherside of an implant body 1110.

According to some embodiments, as the suture tail or free end 1190 istensioned or pulled away from the implant body 1110, the suture loop1180 is tightened, thereby urging the bone anchor 1230 toward the openend 1140 of the implant body 1110. In some arrangements, manipulation ofone or more of the tails or free ends of the suture loop 1180 can alsoradially expand or otherwise deploy the expandable element 1170 (or, inother configurations, a second bone anchor). For example, manipulationof a tail or free end of the suture loop can advance the wedge or insert1250 at least partially into the longitudinal channel 1175 of theexpandable element. Accordingly, the expandable element 1170 can beurged at least partially radially outwardly to engage bone tissue andsecure the anchor within the corresponding bone bore. In someembodiments, a single tail or free end of the suture loop is manipulatedto radially expand an expandable element 1170 (or other bone anchor) andto simultaneously apply tension between bone anchoring elementspositioned on opposite ends of the implant (e.g., bone anchors,expandable elements, etc.). Alternatively, however, the suture loop1180, the knot and/or other components of the tension assembly 1120 canbe designed and otherwise configured to separately or individuallydeploy one or more anchoring members (e.g. anchors, expandable elements,etc.) and to apply tension to the implant.

As noted herein, according to some embodiments, such as the implant 1000of FIG. 10, at least one bone anchor or bone engaging element 1170 isintegrated into the implant body 1110. Thus, under such a configuration,the implant body 1110 can form an interference or friction fit with thebore hole within the selected bone, at least along the location of theimplant body that includes the expandable element or other bone engagingfeatures. Such embodiments can reduce the complexity of the implant,improve the rigidity and robustness of an orthopedic fusion procedureand/or provide additional benefits and advantages.

With continued reference to FIG. 10, the bone anchor 1230 can include anouter anchor tube 1300 and an insert 1310 disposed partially within theanchor tube 1300. The insert 1310 can include a head portion 1320 thatcontacts and bears upon an end of the anchor tube 1300. In someembodiments, the anchor tube 1300 includes a plurality of deflectablefingers or other engaging members 1330 that are configured to bedeflectable radially inwardly when advanced through a delivery cannulaand/or bone bore. Such fingers or engaging members 1330 can be biasedradially outwardly when properly positioned within a bone bore, suchthat they can engage a surface of the bore to secure the bone anchor1230 thereto. The eyelet or other securement member 1220 of the boneanchor can be coupled to the head portion 1320 of the insert 1310, suchthat when tension is applied to the eyelet or other securement member1220 (e.g., via pulling of the suture loop 1180 that is attached to theeyelet or other securement member), such a tensile force is transmittedto the head portion 1320 and adjacent portions of the anchor.

In some embodiments, once an anchor 1230 is delivered and deployedwithin a bone bore and its fingers or engaging members assume a radiallyexpanded orientation (e.g., as illustrated in FIG. 10), movement of theanchor 1230 in the direction of the implant body 1110 is prevented orlimited. This can be due, at least in part, on the orientation of thefingers or bone engaging members 1330 relative to the direction oftension applied to the anchor. In some embodiments, the anchor comprisesone or more biocompatible rigid, semi-rigid and/or flexible materialsthat provide the desired structural characteristics (e.g., strength,durability, flexibility, longevity, etc.) to the overall implant design.For example, in some embodiments, the insert 1310 of the anchor and/orthe anchor tube 1300, including the deployable fingers or other engagingmembers extending therefrom, can include one or more polymeric materials(e.g., polyether ether ketone or PEEK, polyphenylene, polysulfone,polyethylene, etc.). In other embodiments, at least one or more of thecomponents of the bone anchor 1230 comprise other materials, either inlieu of or in addition to suitable polymeric materials, that provide thedesired properties to the anchor, such as, for example, metals or metalalloys (e.g., stainless steel, Nitinol or other shape memory materials,etc.), elastomeric materials (e.g., biocompatible rubbers) and/or thelike. According to one embodiment, the insert 1310 of the anchorcomprises PEEK and/or other polymeric materials, while the anchor tube1300 comprises Nitinol, another shape memory material and/or anothermetal or alloy configured to at least partially radially expand (e.g.,self-expand, with the assistance of a separate member, etc.) to engageadjacent bone tissue.

Additional details regarding the bone anchors illustrated herein areprovided in U.S. Patent Publication No. 2013/0211451, filed as U.S.patent application Ser. No. 13/673,626 on Nov. 9, 2012 and published onAug. 15, 2013, the entirety of which is incorporated by reference hereinand explicitly made a part of this specification. In other embodiments,other bone anchor configurations can be employed. The bone anchor 1230can include any configuration suitable to permit the bone anchor 1230 tobe inserted into a bone bore, and to thereafter engage the bone boresurface so as to resist being pulled from the bone bore in the directionopposite the insertion direction (e.g., in the direction of the implantbody). Such anchors (e.g., those discussed with reference to FIG. 10)can be incorporated into implant disclosed herein, such as, for example,without limitation, the implant of FIGS. 12A-12C.

FIG. 11 illustrates a side view of an alternative embodiment of a boneanchor 1390 that can be used in the implant 1000 in lieu of the boneanchor 1230 (or in any other implant design disclosed herein). As shown,the bone anchor 1390 includes an outer anchor tube 1400, an insert 1410,and an elastic member or portion 1415. The insert 1410 can include ahead portion 1420 and the anchor tube 1400 that comprises a plurality ofdeflectable fingers or engaging members 1430 for contacting and engagingthe bone surface of a bone bore when inserted and positioned therein. Inaddition, an eyelet or other securement feature 1220 can be secured toor incorporated into the head portion 1420.

With continued reference to FIG. 11, the bone anchor 1390 can compriseone or more elastic members 1415 to provide for a variable compressiveforce to the anchor tube 1400 when a tensile force is applied to theinsert 1410 (e.g., via a suture loop mechanically coupled thereto). Asshown, the elastic member 1415 can comprise a tube or other structurepositioned between the head portion 1420 of the insert 1410 and an end1440 of the anchor tube 1400. Thus, in some embodiments, when thefingers or other deployable members 1430 engage an adjacent bone surfaceand tension is applied to the eyelet or other securement feature 1220,the head portion 1420 of the insert 1410 can abut and bear upon theelastic member 1415. In turn, the elastic member can bear upon the end1425 of the anchor tube 1400. In some embodiments, the elastic member1415 comprises one or more elastic or semi-elastic materials, such as,for example, rubbers, other elastomers, polymeric materials, resilientmetals and/or alloys, other resilient or compressible materials and/orthe like. Accordingly, in such configurations, a variable compressiveforce can be applied to the anchor tube 1400 in response to a tensileforce on the eyelet or other securement feature 1220. In addition, theelastic member 1415 can operate similar to a compression spring, suchthat it maintains a compressive force on the anchor tube 1400, even astension in the eyelet or other securement feature 1220 is relaxed oreased. According to some embodiments, the elastic element 1415 cancomprise a variety of biocompatible, elastomeric and/or other materials,such as, without limitation, silicone rubbers, polyisoprene, otherelastomeric and/or resilient materials and/or the like. Such anchors(e.g., those discussed with reference to FIG. 11) can be incorporatedinto implant disclosed herein, such as, for example, without limitation,the implant of FIGS. 12A-12C.

FIGS. 12A and 12B illustrate another embodiment of an implant 1600 thatcan be used in a joint arthrodesis or fusion procedure to treat hammertoe or another orthopedic deformity. According to some embodiments, theimplant 1600 comprises an implant body 1610 (having a proximal end 1612and a distal end 1615), a pair of bone anchors 1618, 1619, and a tensionassembly 1620. In some embodiments, the tension assembly 1620 comprisesa suture system or construct that includes one or more strands ofsuture. In some embodiments, the implant body 1610 comprises alongitudinal lumen 1622 that extends to openings along the proximal anddistal ends 1612, 1615 of the implant body 1610. In addition, as withother implant embodiments described herein, the suture or othercomponent of the tension assembly 1620 can extend into the internallumen of the implant body 1610 through a side-hole or window 1623positioned along a portion of the implant body 1610. In someembodiments, such a side-hole or window is located along or near themiddle of the implant body (e.g., generally between the proximal anddistal ends 1612, 1615 of the implant body). However, in otherembodiments, the side-hole or window can be located closer to theproximal end 1612 or the distal end 1615 of the implant body 1610, asdesired or required for a particular application or use.

With continued reference to FIG. 12A, the tension assembly 1620 cancomprise a pair of opposed suture loops 1625, 1630, each of which isconnected to one of the bone anchors 1618, 1619 (e.g., via eyelets orother securement members 1635, 1640). In addition, the tension assembly1620 can comprise one or more locking or friction elements or portions1650, 1655 formed in the suture construct of the tension assembly 1620,and a pair of suture tails or ends 1660, 1665. As discussed in greaterdetail herein (e.g., with reference to the embodiments of FIGS. 19 and20), the locking or friction elements or portions 1650, 1655 of thesuture system can include portions in which a suture strand is routedthrough a portion of itself (e.g., through a cannulated portion of thesuture) over a particular distance or length. Friction or otherresistive forces created between the suture strand routed through aninterior portion of itself (e.g., via an opening in the suture sidewall)over the length of such elements or portions 1650, 1655 can help preventor reduce the likelihood of relative movement of the adjacent portionsof the suture. In such a knotless construct, the resulting friction orinterference fit created within the suture loop at these locations helpsmaintain the position of the suture tails or ends 1660, 1665 that arerouted through the side-hole or window 1623 to the exterior of theimplant body 1610, even when the suture tails or ends are subjected to acertain level of tension (e.g., when the surgeon pulls the suture endsto create tension within the tension assembly). Thus, each of thelocking elements 1650, 1655 can include a knotless construct, in which asection suture is routed through one sidewall of the tubular suturematerial and extends within the tubular suture material for apre-defined distance before exiting the sidewall. Accordingly, uponapplication of tension to the suture system by a surgeon, the tensioncan be applied to and advantageously maintained between the opposinganchors of the implant.

Although the implant body 1610 illustrated herein is shown as generallystraight, in other embodiments, the implant body 1610 may be formed witha bend having a desired angle or shape. In some embodiments, the anglecan vary between 0 and 30 degrees (e.g., 0, 1, 2, 3, 4, 5, 6, 7, 8, 9,10, 11, 12, 13, 14, 15, 16, 17, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28,29, 30 degrees, values between the foregoing angle ranges, etc.),greater than 30 degrees (e.g., 30-40, 40-50, 50-60 degrees, greater than60 degrees, etc.), etc. In some embodiments, such a bend or angle in theimplant body 1610 can approximate the natural angle of the phalangealbones adjacent the targeted joint (e.g., the proximal and intermediatephalanges of a subject's foot, other phalangeal bones of a subject'sfoot or hand, etc.). Such a bend can help position the subject's toes,fingers or other bones in a more proper alignment and orientationfollowing implantation of an implant. In some embodiments, the implantcomprises two or more bends or angles. In other embodiments, the implantbody comprises a non-linear shape along one or more portions. Forexample, one or more sections of the implant body can include a roundedor curved shape, a sinusoidal shape, an irregular shape and/or the like.

According to some embodiments, each tail or free end 1660, 1665 can beassociated with a corresponding suture loop 1625, 1630. Thus, asdiscussed in greater detail herein, the surgeon can pull or otherwisemanipulate the tails or free ends 1660, 1665 that extend to the exteriorof the implant body 1610 to reduce or eliminate any slack in thecorresponding suture loop 1625, 1630, and thus, provide a desired levelof tension to the implant. For example, pulling of the tails or freeends can generate a tensile force between the two anchors 1618, 1619,resulting in compressing the adjacent bones in which the anchors aresecured toward one another. Such a compressive force can help maintaincontact between adjacent bone surfaces to facilitate in the arthrodesisor fusion process. Thus, applying tension to the suture tails 1660, 1665allows the surgeon to selectively apply tension to the respective sutureloops 1625, 1630, and thus, to the overall implant.

In other embodiments, the locking elements or portions 1650, 1655 of thesuture loops include one or more other locking features, elements,designs or configurations (e.g., one-way knot constructs, separatecomponents or devices that restrict relative movement between twoadjacent portions of a suture strand, etc.). As discussed in greaterdetail herein, in the embodiment illustrated in FIG. 12A, the tensionassembly 1620 can also be used as a repositioning element to adjust theaxial or longitudinal position of the implant body 1610 during theimplantation procedure. For example, once the implant body 1610 has beeninserted within corresponding bores of proximal and distal bones (orproximal and distal portions of a bone, in a case of a fracture), thetension assembly 1620 can be used to move the implant body 1610 deeperinto the proximal or distal bore, as desired or required. In someembodiments, for instance, a surgeon can manipulate the tails or freeends 1660, 1665 of the suture strands that pass through the side-hole orwindow 1623 of the implant body 1610 to accomplish the desiredrepositioning.

According to some embodiments, the implant body 1610 includes a rigid orsemi-rigid structure having a hexagonal cross-sectional shape. In otherembodiments, however, the implant body 1610 can include a differentcross-sectional shape, such as, for example, circular, oval, square,rectangular, triangular, other polygonal, irregular and/or the like. Insome embodiments, the use of an implant body 1110 having a polygonalshape helps ensure that the implant body will not rotate or otherwisemove undesirably after completion of an implantation procedure. Forexample, the corners formed by the polygonal shape can provide forimproved engagement with adjacent bone surfaces to reduce the likelihoodof rotation or other movement when the implant is subject to variousforces or moments post-implantation.

In some embodiments, the implant body 1610 comprises one or morebiocompatible rigid, semi-rigid and/or flexible materials that providethe desired structural characteristics (e.g., strength, durability,flexibility, longevity, etc.) to the overall implant design. Forexample, in some embodiments, the implant body 1610 can include one ormore polymeric materials (e.g., polyether ether ketone or PEEK,polyphenylene, polysulfone, polyethylene, etc.). In other embodiments,at least one or more of the components of the implant body 1610 compriseother materials, either in lieu of or in addition to suitable polymericmaterials, that provide the desired properties to the anchor, such as,for example, metals or metal alloys (e.g., stainless steel, Nitinol orother shape memory materials, etc.), elastomeric materials (e.g.,biocompatible rubbers) and/or the like. In some embodiments, the implantbody comprises both a polymeric material (e.g., PEEK) and a metal oralloy (e.g., Nitinol, stainless steel, etc.).

According to some embodiments, the length of the implant body 1610 canbe 5-50 mm (e.g., 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19,20, 21, 22, 23, 24, 25, 25-30, 30-35, 35-40, 40-45, 45-50 mm, lengthsbetween the foregoing ranges, etc.). In other embodiments, the length ofthe implant body is less than about 5 mm (e.g., 0.5, 1, 1.5, 2, 2.5, 3,3.5, 4, 4.5, 5 mm, lengths between the foregoing values, less than 0.5mm, etc.). In one embodiment, an implant body 1610 used for repairinghammer toe in an adult subject is about 15 to 20 mm long (e.g., 15, 16,17, 18, 19, 20 mm long).

In some embodiments, the outer cross-sectional dimension of the implantbody 1610 can be 1-5 mm (e.g., 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 mm,dimensions between the foregoing values, etc.). In other arrangements,the outer cross-sectional dimension of the implant body 1610 is lessthan 1 mm (e.g., 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 0.95, 1mm, dimensions between the foregoing values, less than about 0.1 mm,etc.) or greater than 5 mm (e.g., 5-10, 10-15, 15-20 mm, greater than 20mm, etc.), as desired or required by a particular application or use.

The proximal and distal bone anchors 1618, 1619 included in the implantof FIG. 12A can be similar or identical to those discussed herein withreference to other embodiments, such as, for example, the anchor 1230incorporated into the implant design of FIG. 10 or the bone anchor 1390illustrated in FIG. 11. In some embodiments, the anchors comprise one ormore biocompatible rigid, semi-rigid and/or flexible materials thatprovide the desired structural characteristics (e.g., strength,durability, flexibility, longevity, etc.) to the overall implant design.For example, in some embodiments, the insert of the anchor and/or theanchor tube, including the deployable fingers or other engaging membersextending therefrom, can include one or more polymeric materials (e.g.,polyether ether ketone or PEEK, polyphenylene, polysulfone,polyethylene, etc.). In other embodiments, at least one or more of thecomponents of the bone anchor comprise other materials, either in lieuof or in addition to suitable polymeric materials, that provide thedesired properties to the anchor, such as, for example, metals or metalalloys (e.g., stainless steel, Nitinol or other shape memory materials,etc.), elastomeric materials (e.g., biocompatible rubbers) and/or thelike. According to one embodiment, the insert of the anchor comprisesPEEK and/or other polymeric materials, while the anchor tube comprisesNitinol, another shape memory material and/or another metal or alloyconfigured to at least partially radially expand (e.g., self-expand,with the assistance of a separate member, etc.) to engage adjacent bonetissue.

Additional details regarding the bone anchors illustrated herein areprovided in U.S. Patent Publication No. 2013/0211451, filed as U.S.patent application Ser. No. 13/673,626 on Nov. 9, 2012 and published onAug. 15, 2013, the entirety of which is incorporated by reference hereinand explicitly made a part of this specification. In other embodiments,other bone anchor configurations can be employed into the implant designillustrated in FIG. 12A. The bone anchors can include any configurationsuitable to permit the bone anchors to be inserted into a bone bore, andto thereafter engage the bone bore surface so as to resist being pulledfrom the bone bore in the direction opposite the insertion direction(e.g., in the direction of the implant body).

With continued reference to FIG. 12A, in some embodiments, the outerdiameter or cross-sectional dimension of the bone anchors 1618 isidentical or similar to the outer cross-sectional dimension of theadjacent implant body 1610. However, in other arrangements, the outerdiameter or cross-sectional dimension of the bone anchors 1618 can begreater than or smaller than the outer cross-sectional dimension of theadjacent implant body 1610. For example, the outer diameter orcross-sectional dimension of the bone anchors 1618 can be about 0-20%(e.g., 0-1, 1-2, 2-3, 3-4, 4-5, 5-6, 6-7, 7-8, 8-9, 9-10, 10-11, 11-12,12-13, 13-14, 14-15, 15-16, 16-17, 18-19, 9-20%, percentages between theforegoing, etc.) larger or smaller than the outer cross-sectionaldimension of the adjacent implant body 1610, as desired or required.

The implant body 1610 and/or the bone anchors 1618, 1619 can be providedin a variety of sizes and shapes to accommodate for differentindications, applications, subject and/or the like. Such implant bodiesand/or anchors can be provided to the surgeon or other user in a kit.For example, a kit can include implant bodies 1610 of varying lengthsand/or cross-sectional dimensions. In some embodiments, a kit includesbone anchors of different diameters or sizes, implants of varyingcross-sectional dimensions and/or lengths and suture loops of varyingdesigns, sizes, lengths and/or other properties. Thus, a surgeon orother practitioner can advantageously customize a procedure by combiningvarious components. This can help provide for a more successfultreatment procedure by using components that are best sized, shapedand/or otherwise configured for a specific application or use. In otherembodiments, the implant body is configured be cut or otherwise reshapedin order to modify the implant for a particular use or application.Thus, is some embodiments, the implant body is provided in one or morelengths that can be shortened. In some embodiments, the implant bodycomprises materials and/or a configuration that is configured to be cutor otherwise shortened. For example, in some embodiments, the implantbody can include segments that are scored, perforated, undermined and/orotherwise configured to be cut along certain predetermined locations.

According to some embodiments, the proximal bone anchor 1618 and theproximal end 1612 of the implant body 1610 can be inserted into a boreof a proximal bone (e.g., a proximal phalange) such that the distal end1615 of the implant body extends distally from the proximal phalange bya desired first distance. In some embodiments, for example, the firstdistance is approximately 4 to 8 mm (e.g., 4, 5, 6, 7, 8 mm, distancesbetween the foregoing values, etc.). Such a protruding distance beyondthe proximal bone permits the distal bone to be safely and relativelyeasily placed over the protruding portion of the implant body. In someembodiments, the distal bone anchor 1619 can be seated in the bone boreof a distal bone (or distal bone portion), such as the intermediatephalange of a subject's foot. In such configurations, the tensionassembly 1620 can include sufficient slack to allow the proximal boneanchor 1618 and the distal bone anchor 1619 to be separately seated inthe respective bone bores while the proximal and intermediate phalangesare displaced from one another.

According to some embodiments, with reference to the implant of FIG.12A, the distal bone (e.g., intermediate phalange) can then bepositioned adjacent to the proximal bone (e.g., proximal phalange) suchthat the distal end 1615 of the implant body 1610 extends into the bonebore of the distal bone. Slack in the proximal suture loop 1630 can betaken up (e.g., reduced or eliminated) by applying tension to thecorresponding suture tail or free end 1665. In some embodiments, indoing so, the interaction between the suture tail or free end 1665 andthe inner surface of the side-hole or window 1623 can displace theimplant body 1620 distally within the bone bores. In one embodiment, theposition of the implant body 1620 within the bone bores may be adjusteduntil substantially equal lengths of the implant body 1610 arepositioned within each of the phalanges (as can be visually confirmedwhen the side-hole 1623 is aligned with the joint between thephalanges). However, in other embodiments, it may be desirable to movethe implant body deeper into the distal or proximal bore, such that therelative length of the implant body positioned in the distal andproximal bores is unequal. For example, in some embodiments a longerportion of the implant body (e.g., 50-60, 60-70, 70-80, 80-90% of theoverall implant body length) is positioned within the distal bore or theproximal bore of the adjacent bones or bone portions along which fusionis sought, as desired or required. In one embodiment, the implant body1610 is urged as deep as possible into the distal bore, such that adistal end of the implant body 1610 abuts and contacts the distal anchor1619 positioned and secured within the distal bore.

With the implant body 1610 positioned as desired, one or more of thesuture tails or free ends 1660, 1665 can be pulled so as to applytension to the suture loops 1625, 1630, thus drawing the bone anchors1618, 1619, and consequently, the proximal and intermediate phalangestoward one another. In doing so, the joint between the phalanges isplaced in compression. As discussed in greater detail herein, theknotless locking or friction elements 1650, 1655 along each of thesuture loops 1625, 1630 are configured to maintain this compressionpost-implantation. In some embodiments, at the end of an implantationprocedure, the surgeon can optionally secure the suture free ends toeach other (e.g., using one or more knots), trim such free ends and/orperform one or more other steps, ad desired or required.

According to some embodiments, once the implant body 1610 can beinitially inserted within the proximal and distal bores and subsequentlymoved to a desired axial position (e.g., deeper into the distal bore,deeper into the proximal bore, etc., the side hole or window of theimplant body may not be located at or near the targeted joint beingtreated. For example, the window 1623, and thus the suture tails or freeends that pass therethrough, can be located a particular distance (e.g.,0-10 mm, 0-1, 1-2, 2-3, 3-4, 4-5, 5-6,6-7, 7-8, 9, 10 mm, greater than10 mm, distances between the foregoing values, etc.) distal or proximalto the joint or other bone interface. Thus, in some embodiments, oncethe implant body is moved either proximally or distally into acorresponding bone bore, the free end or tail of the suture systemexiting the window can be routed along the outside of the implant bodyuntil it reached the joint. Thus, in some embodiments, the suture lineor other elastomeric component comprising the suture loop and otherportions of the suture system can comprises the necessary properties(e.g., strength, durability, flexibility, etc.) to transmit the tensileforces along the entire suture length, include any portion that issituation between the outside of the implant body and the insidediameter or portion of a corresponding bone bore.

In other embodiments, the distal (or proximal) bore can be createdentirely through the targeted bone (e.g., phalange). Thus, the tensionsystem in the implant of FIG. 12A (and/or any other implant disclosedherein) can be reconfigured to that the tails or free ends of a suturecan be routed entirely through a bone to an opening opposite of thetargeted joint being fused or otherwise treated. Thus, for example, forthe implant of FIG. 12A, once the free ends or tails 1660, 1665 of thesuture system 1620 exit the window 1623 of the implant body 1610, theycan be routed distally or proximally (e.g., past the correspondinganchors 1619, 1618), along an area generally between the outside of theanchor and the insider diameter of the bone bore, toward a distal orproximal opening of the adjacent bones being fused.

As shown in FIG. 12C, an elastomeric insert 1690 can be positioned onone or more sides of the implant body 1610 (e.g., between the implantbody and the adjacent anchor or other bone engaging element). Such aninsert or other component 1690 can include a spring (e.g., coil spring),another elastomeric, compressible or resilient sleeve, component ormaterial (e.g., rubber insert) and/or the like. In some embodiments,such an insert 1690 can help increase or otherwise enhance the tensioncreated within an implant once the tension system is manipulated. Forexample, in one embodiment, the insert 1690 is sized, shaped andotherwise configured so that, upon application of tension to theimplant, the insert is squeezed or otherwise positioned between one endof the implant body and an adjacent anchor. Thus, as a result of suchcontact, the insert 1690 can be at least partially axially orlongitudinally compressed to further increase the tension in the implant(e.g., and thus, increase the compressive forces maintained betweenadjacent bones being fused). Such an insert can be incorporated into anyof the implant embodiments disclosed herein or variations thereof.

In some embodiments, as discussed herein, before an implant (e.g., theimplant illustrated in FIGS. 12A and 12B) is positioned within a joint,certain preparatory steps can be performed to the adjacent bones of thejoint. For example, the joint can be at least partially exposed orresected and the adjacent bone surfaces of the joint can undergo aparticular rasping or other tissue removal step. For instance, a rasp orother bone cutting tool or method can be used to remove cartilage and/orbone tissue along each adjacent bone, resulting in bone to bone (e.g.,bleeding bone to bleeding bone) contact. Further, before, during orafter implantation of the implant into the joint, one or more graft orother materials or inserts can be positioned along the joint to promotefusion of the joint.

According to some embodiments, a proximal and/or distal portion of theimplant body (e.g., along either side of a joint or other point offusion) is configured to extend across two or more bones (e.g.,phalanges). Thus, in some embodiments, an implant body is configured tospan across three or more bones.

FIGS. 13-18 schematically illustrate sequential steps of a method oftreating a foot joint deformity, such as, for example, hammer toe, usingthe implantable orthopedic repair implant 1000, according to oneembodiment. During the arthrodesis procedure, portions of a pair ofadjacent bones to selected to be fused that create the joint areresected and a bore hole is drilled into each the adjacent bones suchthat are substantially parallel and opposing. The drilled holes arelarge enough to accept the implant body 1110. Such an embodiment can beused with any configuration of an implant disclosed herein, including,without limitation, the implants depicted in FIGS. 2A, 10 and 12A.

In the illustrated embodiment, as shown in FIG. 13, bone bores 1500,1510 are formed, respectively, in the proximal and intermediatephalanges PB, DB after dissecting the soft tissues connecting thephalanges. In the illustrated embodiment, the bone bores 1500, 1510 canbe formed using a bone drill, awl or similar device 1520. In someembodiments, the bone bores 1500, 1510 are drilled to a predetermineddepth, as dictated by the implanting orthopedic specialist or asrequired by a particular procedure or protocol.

According to any of the implantations and fusion methods and proceduresdisclosed herein, preparation of the targeted bone surfaces (e.g.,decertification, drilling, etc.) can be performed, at least in part,using the tools and other devices disclosed in U.S. Provisional PatentNo. 61/887,132, filed Oct. 4, 2013 and titled CIRCULATING BONE RASP, theentirety of which is hereby incorporated by reference herein and made apart of this specification.

Next, as shown in FIG. 14, the implant 1000 can be partially insertedinto the bone bore 1500 with the aid of a delivery tool 1550. In theillustrated embodiment, the delivery tool 1550 comprises a cannulatedmain body 1560 and a pull tab 1570. As shown, the distal end 1145 of theimplant body 1110 can be received within the cannulated main body 1560,and the suture loop of the positioning element 1125 can be secured tothe pull tab 1570. As further shown, in the configuration of FIG. 13,the bone anchor 1230 of the implant 1100 abuts the open proximal end1140 of the implant body 1110. Although not illustrated in FIG. 13, insuch a configuration, slack can exist in the tension assembly 1120 thatis attached to the main body 1560 of the delivery tool 1550. Such slackcan permit for the subsequent repositioning of the implant body 1110 asdiscussed in greater detail herein. As further shown in FIG. 13, theimplant 1100 can be initially inserted fully into the bone bore 1500.

As shown in FIG. 15, according to some embodiments, the cannulated mainbody 1560 of the delivery tool 1550 can be removed from the distal end1145 of the implant body 1110, and the pull tab 1570 can be separatedfrom the cannulated main body 1560. As further shown in FIG. 15, thepositioning element 1125 can be attached to the pull tab 1570, and thesuture tail 1190 of the tension assembly 1120 can be attached to thecannulated main body 1560. Further, the distal end 1145 of the implantbody 1110 can extend distally from the proximal bone PB (e.g., proximalphalange) by a pre-determined distance based on the length of theimplant body 1110 and the insertion depth into the bone bore 1500. Invarious embodiments, such a distance is relatively small to facilitateease of subsequent steps in the repair procedure. The distance can beselected to facilitate positioning the intermediate phalange proximatethe interphalangeal joint to be repaired. In some embodiments, theprocedure is performed, and the implant 1100 is configured, so that thedistal end 1145 initially extends about 5 mm from the distal face of theproximal bone PB (e.g., proximal phalange) upon initial insertion of theimplant body 1110 into the bone bore 1500. However, in otherembodiments, such a distance can be greater or less than 5 mm (e.g., 1,2, 3, 4, 5, 6, 7, 8, 9, 10 mm, greater than 10 mm, etc.).

With reference to FIG. 16, the intermediate phalange DB can bepositioned adjacent the proximal phalange PB, with the distal end 1145of the implant body 1110 at least partially inserted into the bone bore1510 of the intermediate phalange DB. As shown in FIG. 17, while holdingthe proximal and intermediate phalanges in place, the surgeon can applytension to the pull tab 1570 (as indicated by the arrow T), which inturn causes the implant body 1110 to be displaced distally within thebone bores 1500, 1510 (as indicated by the arrow D). As can be seen inFIG. 17, the implant body 1110 can thus extend further into the bonebore 1110 than in the earlier phase of the repair method illustrated inFIG. 16. This can advantageously enhance the stability of the joint Jupon completion of a fusion procedure.

In some embodiments, because the bone anchor 1230 has engaged the bonesurfaces within the bone bore 1500, movement in the distal direction isgenerally resisted. Accordingly, displacement of the implant body 1110can result in separation between the proximal end 1140 of the implantbody 1110 and the bone anchor 1230, with slack in the tension assembly1120 being partially or wholly taken up by such separation.

With reference to FIG. 18, applying tension to the main body 1560 (asindicated by the arrow P) can apply tension to the tension assembly 1120between the bone anchor 1230 and the expandable element 1170 at thedistal end 1145 of the implant body 1110. In some embodiments, since thebone anchor 1230 and the expandable element 1170 are positively engagedwith bone surfaces within the respective bone bores 1500, 1510, tensionapplied to the tension assembly 1120 can cause the adjacent bones PB, DB(e.g., proximal and intermediate phalanges) to be drawn toward oneanother so as to place the joint J in compression (as indicated by thearrows C in FIG. 18). In various embodiments, the tension assembly 1120,and in particular, the sliding knot 1200, are configured to retain thetension assembly under tension, thus maintaining compression on thejoint J post-implantation.

In some embodiments, the tension assembly 1120 and the positioningelement 1125 are formed of separate suture structures. In otherembodiments, however, these components may be combined, at leastpartially, into a single suture structure or construct that isoperatively coupled to the bone anchor 1230 and the implant body 1110.Also, in various embodiments, the steps of applying tension to thepositioning element 1125 and applying tension between the bone anchor1230 and the expandable element 1170 can be performed as separate steps(as shown in FIGS. 17 and 18). Alternatively, such steps can beperformed substantially concurrently by applying tension to a singlesuture tail of an appropriately constructed suture construct.

FIGS. 19 and 20 illustrate different views of one embodiment of aknotless suture system configured to be used in a tension assembly 1620for any of the implant configurations disclosed herein. As shown, thesuture system can include two separate suture strands 1621A, 1621B thatcan be secured to each other to form a knot K or other structure. Asdiscussed herein with reference to several implant embodiments, such aknot K or other joining structure can be strategically positioned withinan interior lumen of an implant body 1610. In some embodiments, the knotK can include an outer cross-sectional dimension that is greater thanthe size of side-hole or window of the implant body 1610, therebysecurely maintaining the knot K and other portions of the tension system1620 within an interior of the implant body 1610. In alternativeembodiments, the tension system 1620 includes only a single strand ofsuture.

With continued reference to the illustrated embodiment, free ends ortails 1660, 1665 of suture loops 1625, 1630 can pass through a side-holeor window of the implant body and exit to the exterior of the implantbody. In some embodiments, as discussed in greater detail above, asurgeon can manipulate (e.g. pull) these free ends or tails to providetension to the implant and create compression in the joint targeted forfusion.

In some embodiments, as illustrated in the detailed schematic view ofFIG. 20, the suture strand can loop around an eyelet or securementfeature 1635 of a bone anchor or other bone engaging member and passthrough an interior portion of itself during the return loop along alocking or friction element or portion 1650 of the loop. In someembodiments, the suture is cannulated to facilitate the passage of thesuture through its interior along such a portion 1650. As noted herein,such a configuration helps create a knotless suture system that iscapable of maintaining a threshold level of tension to the implant. Forexample, as the surgeon pulls on the free end or tail 1660, slack insuture loop 1625 is reduced or eliminated. With reference to FIG. 20, asthe free end 1660 is pulled, a portion of the suture looping around theeyelet or other securement feature 1635 of the anchor 1618 passesthrough the interior of a section of the suture loop (e.g., along thelocking or friction element or portion 1650). The frictional forcesbetween the suture sections along this friction portion 1650 helpprevent the suture loop from loosening and creating slack in the tensionassembly. Accordingly, the tension created by manipulating the free endsor tails of the sutures can be advantageously maintained without a knotor additional securement feature or method.

According to some embodiments, any of the suture structures disclosedherein comprise surgical suture comprising one or more biocompatiblepolymeric materials, such as, for example, ultra-high-molecular-weightpolyethylene, other types of polyethylene, other polymeric materialsand/or the like. In some configurations, the suture includes one or moreelastomeric materials (e.g., rubber bands or other rubber elastics orcomponents) and/or other elastic materials or features. In oneembodiment, the diameter of the suture is about 0.2 to 0.6 mm (e.g.,0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6 mm, diameter between theforegoing values, etc.). In other embodiments, however, the suturediameter can be greater than 0.6 mm or smaller than 0.2 mm, as desiredor required. In other embodiments, however, the tension system caninclude an elastomeric component or member that is not a suture, but isnevertheless capable to providing the necessary tension to the implantand withstanding the necessary forces, moments and other elements towhich it is subjected. Such an elastomeric component can include aflexible insert and/or the like.

In some embodiments, the locking or friction element or portion 1650 ofa knotless suture system can be configured to withstand a maximum of 5to 20 pounds of force before failing (e.g., 5, 6, 7, 8, 9, 10, 11, 12,13, 14, 15, 16, 17, 18, 19, 20 pounds, values between the foregoing,etc.). In other arrangements, depending on the specific protocol, themaximum fail force can be lower than 5 pounds or greater than 20 pounds,as desired or required. In some embodiments, the end portions of thesuture tails or free ends that are grasped or otherwise manipulated bythe surgeon during a procedure can be configured to comprise a lowermaximum force threshold (e.g., in some embodiments, about 1 to 30% lowerfailure threshold). Such portions can be limited to portions of theimplant's tension assembly that are not routed through an implant body.Thus, if an upper force threshold is realized, the end portions of thesuture tails or free ends (e.g., the portions with the lower forcethreshold) will fail and will be sacrificed to protect the remainingportions of the tension assembly (e.g., the suture loops, the frictionportions, etc.).

To assist in the description of the disclosed embodiments, words such asupward, upper, bottom, downward, lower, rear, front, vertical,horizontal, upstream, downstream have been used above to describedifferent embodiments and/or the accompanying figures. It will beappreciated, however, that the different embodiments, whetherillustrated or not, can be located and oriented in a variety of desiredpositions.

Although several embodiments and examples are disclosed herein, thepresent application extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of theinventions and modifications and equivalents thereof. It is alsocontemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments may be made and stillfall within the scope of the inventions. Accordingly, it should beunderstood that various features and aspects of the disclosedembodiments can be combine with or substituted for one another in orderto form varying modes of the disclosed inventions. Thus, it is intendedthat the scope of the present inventions herein disclosed should not belimited by the particular disclosed embodiments described above, butshould be determined only by a fair reading of the claims that follow.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the inventions are not to be limited to the particularforms or methods disclosed, but, to the contrary, the inventions are tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the various embodiments described and theappended claims. Any methods disclosed herein need not be performed inthe order recited. The methods disclosed herein include certain actionstaken by a practitioner; however, they can also include any third-partyinstruction of those actions, either expressly or by implication. Forexample, actions such as “positioning a proximal or distal end of theimplant body” include “instructing positioning a proximal or distal endof the implant body.” The ranges disclosed herein also encompass any andall overlap, sub-ranges, and combinations thereof. Language such as “upto,” “at least,” “greater than,” “less than,” “between,” and the likeincludes the number recited. Numbers preceded by a term such as “about”or “approximately” include the recited numbers. For example, “about 10mm” includes “10 mm.” Terms or phrases preceded by a term such as“substantially” include the recited term or phrase. For example,“substantially parallel” includes “parallel.”

What is claimed is:
 1. An implant for correcting a deformity in or near a joint of a subject, comprising: an implant body comprising: an internal lumen extending from a first end to a second end of the implant body; a wall that defines the internal lumen; and an expandable element provided at the first end of the implant body, wherein the expandable element forms an integrated bone anchor, and wherein the implant body is rigid; and wherein the implant body comprises a suture side hole extending through the wall of the implant body, the suture side hole being positioned between the first and second ends of the implant body, and wherein the suture side hole provides access to the internal lumen from an exterior of the implant body; and a tension assembly comprising a wedge insert and a second bone anchor, wherein the wedge insert is positioned at the integrated bone anchor of the implant body and the second bone anchor is positioned on an opposite side of the implant body; the tension assembly further comprising at least one adjustable suture loop coupling the second bone anchor to the wedge insert, wherein at least a portion of the at least one adjustable suture loop is positioned within the internal lumen of the implant body; wherein the at least one adjustable suture loop comprises at least one suture tail that extends through the suture side hole and to an exterior of the implant body, wherein, upon deployment and fixation of the integrated bone anchor and the second bone anchor within bone bores of a subject and upon the application of tension to the at least one suture tail in a direction away from the implant body, a tension in the at least one adjustable suture loop between the wedge insert and the second bone anchors is increased.
 2. The implant of claim 1, wherein the first end of the implant body comprises a longitudinal channel and the wedge insert is positioned within the longitudinal channel, wherein the increased tension in the at least one adjustable suture loop pulls the second bone anchor toward the implant body and pulls the wedge insert further into the longitudinal channel causing the expandable element to at least partially radially expand outwardly.
 3. The implant of claim 1, further comprising a positioning element located along the implant body, the positioning element being configured to facilitate adjustment of the implant body within corresponding bone bores of a subject once the implant has been located therein, wherein the at least one adjustable suture loop comprises at least one knotless construct, the at least one knotless construct comprising a portion of the at least one adjustable suture loop routed through an interior of a section of the at least one adjustable suture loop; wherein the wedge insert and the second bone anchor are coupled to the at least one adjustable suture loop; wherein a cross-sectional shape of the implant body is polygonal; and wherein the joint of the subject comprises a toe, and the deformity comprises hammer toe.
 4. The implant of claim 1, wherein the at least one adjustable suture loop comprises at least one knotless construct, the at least one knotless construct comprising a portion of the at least one adjustable suture loop routed through an interior of a section of the at least one adjustable suture loop; and wherein the at least one adjustable suture loop is coupled to the wedge insert and the second bone anchor.
 5. The implant of claim 1, further comprising a sliding knot formed by the at least one adjustable suture loop, wherein the sliding knot is maintained within the internal lumen of the implant body.
 6. The implant of claim 5, wherein an outer dimension of the sliding knot is greater than a diameter of the suture side hole.
 7. The implant of claim 1, wherein the integrated bone anchor comprises an expandable element that is configured to engage bone at an implantation site and the second bone anchor comprises a plurality of deflectable fingers configured to engage bone at an implantation site.
 8. The implant of claim 1, wherein the at least one adjustable suture loop comprises at least one knotless construct, wherein the at least one knotless construct comprises a portion of the at least one adjustable suture loop routed through an interior of a section of the at least one adjustable suture loop.
 9. The implant of claim 1, wherein the implant body comprises a hexagonal or other polygonal cross-sectional shape.
 10. The implant of claim 1, wherein the implant body comprises at least one bend along a length of the implant body. 